Identity
- Trade Name
- LFS 1pkg (10pcs) for UDI for Foil Pack 6422 FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- Laerdal Face Shield (LFS) is a single use medical device intended as a CPR barrier between a rescuer and a patient and to aid rescuers trained in resuscitation, in mouth-to-mouth resuscitation of non-breathing patients. FDA UDI
- Model / Reference
- 20-09490 FDA UDI
- Description
- Laerdal Face Shield (LFS) is a single use medical device intended as a CPR barrier between a rescuer and a patient and to aid rescuers trained in resuscitation, in mouth-to-mouth resuscitation of non-breathing patients. FDA UDI
Identifiers
- Catalog Number
- 20-09490 FDA UDI
- Primary DI / UDI-DI
- 07045432068580 FDA UDI
- 510(k) Number
- K880450 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary resuscitation mask, single-use
LFS 1pkg (10pcs) for UDI for Foil Pack 6422 by Laerdal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K880450 also covers:
- Keyring 1pkg (10pcs) UDI for Foil Pack 6900 — Laerdal Medical Corp.
- Keyring w/LFS x 25 (US) Black — Laerdal Medical Corp.
- Keyring w/LFS x 25 (US) Yellow — Laerdal Medical Corp.
- Keyring w/LFs x 25 (US) Red — Laerdal Medical Corp.
- LFS 1pcs for UDI for Foil Pack 6361 — Laerdal Medical Corp.
- LFS 1pkg (10pcs) for UDI for Foil Pack 6361 — Laerdal Medical Corp.
- LFS 1pkg (10pcs) for UDI for Foil Pack N0918 — Laerdal Medical Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Laerdal Medical Corp.
Sources (1)
- FDA UDI f043c2ba-064d-473d-8fa5-3e57ec1eaa10 37 fields · synced May 30, 2026