Data / Medical devices / United States / Lifeline First Aid LLC
Lifeline First Aid LLC: FDA-registered device maker in Lake Oswego, OR, United States, 1 510(k) clearance
Lifeline First Aid LLC is registered with the FDA (registration 3002714597) in Lake Oswego, OR, United States. It lists 16 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 13, 2003. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002714597
- Address
- 6710 SW McEwan Rd, Lake Oswego, OR, United States, 97035
- Owner or operator
- LIFELINE FIRST AID LLC (9060173)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- December 19, 2008
- Registered through
- 2026
- Brand names listed
- 4255, 841B, 9002, 9003, ACCENT MARKETING, ANJI, ANJI3, BAND013 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Repackager or relabeler | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Sling, Arm, Overhead Supported | ILE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Repackager or relabeler, Specification developer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 13, 2003 | K032781 | BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Blue Sail Plastic & Rubber Products Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 16, 2016 | 74329 | Class II | Terminated | Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one w | First aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (OTC) use. | accessdata.fda.gov |
| July 7, 2011 | 60041 | Not yet classified | Terminated | Base Camp First Aid Kit, Part Number 4150, UPC 0-91966-04150-3, contains 171 pieces. The kit is labeled in parts: "***BASE CAMP FIRST AID KIT***171 PIECE*** 6 IODINE PREP PADS***Lifeline First Aid, LLC***Wilsonville, OR | The first aid kits are recalled because the kits contain Iodine Prep Pad single use wipes which were recalled by Triad. | accessdata.fda.gov |
Compare with other makers
- All makers of First Aid Kit With Drug
- All makers of Disinfectant, Medical Devices
- All makers of First Aid Kit Without Drug
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Tape And Bandage, Adhesive
- All makers of Protector, Skin Pressure
Updated July 6, 2016. 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.