Identity
- Trade Name
- LFS 1pkg (10pcs) for UDI for Foil Pack 6503 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
- 20-09491 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
- 20-09491 FDA UDI
- Primary DI / UDI-DI
- 07045432068597 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
- Not 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
LFS 1pkg (10pcs) for UDI for Foil Pack 6503 by Laerdal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 6422 — 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 96075f8c-fd02-4b84-a37f-fdf0dc8f2639 38 fields · synced May 30, 2026