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Data / Medical devices / United States / Safeguard Us Operating, LLC

Safeguard Us Operating, LLC: FDA-registered device maker in Huntersville, NC, United States, 4 510(k) clearances

Safeguard Us Operating, LLC is registered with the FDA (registration 3008258694) in Huntersville, NC, United States. It lists 34 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 23, 2016. 3 recall events name it as the recalling firm (1 Class I). Registered through 2026. 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 Safeguard Us Operating, LLC
FDA registration number
3008258694
Address
13359 Reese Blvd. E, Huntersville, NC, United States, 28078
Owner or operator
Safeguard US Holdco, Inc. (10031323)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
February 10, 2011
Registered through
2026
Brand names listed
APE, BDX, Battle Bandage, Battle Wrap, Bleeding Control, CROC, Cravat, DART and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Repackager or relabeleraccessdata.fda.gov
Airway, NasopharyngealBTQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
Belt, Pelvic, TractionHSQ1Repackager or relabeleraccessdata.fda.gov
Blood Transfusion KitPOQ2Repackager or relabeleraccessdata.fda.gov
Body Fluid Clean Up KitOKG2Repackager or relabeleraccessdata.fda.gov
Catheter Introducer KitOFC2Repackager or relabeleraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Repackager or relabeler, Specification developeraccessdata.fda.gov
Clamp, VascularDXC2Specification developeraccessdata.fda.gov
Cricothyrotomy KitOGP2Repackager or relabeleraccessdata.fda.gov
Dressing, CompressionMHW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Repackager or relabeler, Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeler, Specification developeraccessdata.fda.gov
First Aid Kit With DrugLRRNRepackager or relabeleraccessdata.fda.gov
First Aid Kit Without DrugOHO1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeler, Specification developeraccessdata.fda.gov
I.V. Start KitLRS2Repackager or relabeleraccessdata.fda.gov
Intravenous Extension Tubing SetOJA2Repackager or relabeleraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Repackager or relabeleraccessdata.fda.gov
Needle, CatheterGCB1Repackager or relabeler, Specification developeraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Repackager or relabeler, Specification developeraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Repackager or relabeleraccessdata.fda.gov
Sheet, BurnFPY1Repackager or relabeler, Specification developeraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Repackager or relabeleraccessdata.fda.gov
Sling, ArmILI1Repackager or relabeleraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Manufactureraccessdata.fda.gov
Stretcher, Hand-CarriedFPP1Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Repackager or relabeler, Specification developeraccessdata.fda.gov
Tube Tracheostomy And Tube CuffJOH2Repackager or relabeler, Specification developeraccessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)BTL2Complaint file establishmentaccessdata.fda.gov
Warmer, Blood, Non-Electromagnetic RadiationBSB2Repackager or relabeleraccessdata.fda.gov
Warmer, Thermal, Infusion FluidLGZ2Repackager 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
June 23, 2016K150404QiF Blood and Fluid WarmerLGZSubstantially EquivalentQuality IN Flow , Ltd.accessdata.fda.gov
July 3, 2014K133528H&H EMERGENCY CRICOTHYROTOMY KITJOHSubstantially EquivalentH & H Medical Corporationaccessdata.fda.gov
March 21, 2014K131877SAVE II, SAVE II BASICBTLSubstantially EquivalentAutomedx, Inc.accessdata.fda.gov
August 11, 2010K102025COMBAT READY CLAMPDXCSubstantially EquivalentCombat Medical Systems, LLCaccessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
September 2, 202699814Class IIOngoingBattle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive Drab, Stocked (Option 1), 81-129-OD; IFAK Bag, Intermediate, BlaCompression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection.accessdata.fda.gov
August 27, 202495183Class IIOngoingHAWK Warming Grid, Item Number: 59-300Incorrect expiration date.accessdata.fda.gov
December 23, 202087084Class ITerminatedValkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as wThere is the potential of a bent or disconnected needle in one of the components of the convenience kits.accessdata.fda.gov

Compare with other makers

Updated October 2, 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.