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Data / Medical devices / United States / North American Rescue, LLC.

North American Rescue, LLC.: FDA-registered device maker in Greer, SC, United States, 5 510(k) clearances

North American Rescue, LLC. is registered with the FDA (registration 3005034064) in Greer, SC, United States. It lists 54 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 20, 2024. 4 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch North American Rescue, LLC.
FDA registration number
3005034064
Address
35 Tedwall Court, Greer, SC, United States, 29650
Owner or operator
NORTH AMERICAN RESCUE, LLC. (9070484)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
February 16, 2005
Registered through
2027
Brand names listed
ADJUSTABLE IV POLE, ARS Decompression Needle, BLOODBORNE PATHOGEN PPE KIT, BOA IV CONSTRICTING BAND, BOA XL IV CONSTRICTING BAND, Bac-Pack Kit, Basic Corpsman Kit, Bedside Hygiene Kit and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Repackager or relabeleraccessdata.fda.gov
Airway Suction KitOFO1Manufactureraccessdata.fda.gov
Airway, NasopharyngealBTQ1Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Repackager or relabeler, Specification developeraccessdata.fda.gov
Bed, ManualFNJ1Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
Blood Transfusion KitPOQ2Manufactureraccessdata.fda.gov
Burn Kit Without DrugOJJ1Manufactureraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Specification developeraccessdata.fda.gov
Clamp, VascularDXC2Manufactureraccessdata.fda.gov
Container, SharpsMMK2Manufactureraccessdata.fda.gov
Cricothyrotomy KitOGP2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Curette, OphthalmicHNZ1Manufactureraccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Specification developeraccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Specification developeraccessdata.fda.gov
Eye TrayOJK2Manufactureraccessdata.fda.gov
Feeding Tube KitPRR2Manufactureraccessdata.fda.gov
Fentanyl And Other Opioid Protection GloveQDO1Repackager or relabeleraccessdata.fda.gov
First Aid Kit With DrugLRRNManufactureraccessdata.fda.gov
First Aid Kit Without DrugOHO1Manufactureraccessdata.fda.gov
Foley Catheter Kit (Excludes Hiv Testing)PPB2Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Specification developeraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Specification developeraccessdata.fda.gov
Hook, TrachealKCH1Repackager or relabeler, Specification developeraccessdata.fda.gov
I.V. Start KitLRS2Manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Manufactureraccessdata.fda.gov
Loop, WireJYQ1Manufactureraccessdata.fda.gov
Magnet, PermanentHPN1Manufactureraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Repackager or relabeleraccessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsOPJ1Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Specification developeraccessdata.fda.gov
OtoscopeERA1Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Repackager or relabeleraccessdata.fda.gov
Personal Protection KitPXC1Manufactureraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Prep Kit – Vaccine InjectionQMT2Manufactureraccessdata.fda.gov
Sheet, BurnFPY1Specification developeraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Repackager or relabeleraccessdata.fda.gov
Sling, ArmILI1Specification developeraccessdata.fda.gov
Speculum, EntEPY1Repackager or relabeleraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Repackager or relabeleraccessdata.fda.gov
Stand, InfusionFOX1Repackager or relabeleraccessdata.fda.gov
Stretcher, Hand-CarriedFPP1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Stretcher, Patient RestraintNZD1Repackager or relabeleraccessdata.fda.gov
Suprapubic Cystostomy Catheter KitNWP2Manufactureraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeleraccessdata.fda.gov
Thoracic Catheter Insertion TrayPYI1Manufactureraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)BTO2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 20, 2024K232654Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)LZASubstantially EquivalentNephron Nitrile, LLCaccessdata.fda.gov
May 31, 2016K152340NAR Sharps Shuttle; NAR Sharps Shuttle Pack of sixMMKSubstantially EquivalentNorth American Rescue, LLCaccessdata.fda.gov
January 3, 2013K123194JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088DXCSubstantially EquivalentNorth American Rescue Products, Inc.accessdata.fda.gov
February 17, 2005K042684WELL LEAD TRACHEOSTOMY TUBEBTOSubstantially EquivalentWell Lead Medical Instrumentsaccessdata.fda.gov
September 17, 2004K042145READY-HEAT BLANKETKMESubstantially EquivalentTechtrade, LLCaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
March 27, 202698697Class IOngoingAIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patientaccessdata.fda.gov
July 1, 202597308Class IIOngoingJUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RDevice used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.accessdata.fda.gov
August 27, 202188603Class IITerminated10 ga ARS Decompression Needle, Part Number ZZ-0298The device includes the incorrect Instructions for Use.accessdata.fda.gov
August 21, 202086340Class IITerminated4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing;Lack of sterility assurance of the 30-0171accessdata.fda.gov

Compare with other makers

Updated April 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.