Identity
- Trade Name
- AmerisourceBergen FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Device Name
- Face Mask with Ties Blue with Pattern, Soft Bill Level 2 FDA UDI
- Model / Reference
- 10545 FDA UDI
- Description
- Face Mask with Ties Blue with Pattern, Soft Bill Level 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00368001105453 FDA UDI
- 510(k) Number
- K770463 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Category: Surgical/medical face mask, non-antimicrobial, single-use
AmerisourceBergen by Bp Pharmaceuticals Laboratories Unlimited Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical face mask, non-antimicrobial, single-use.
- Medicom AssureMask — AMD Medicom Inc · Class II
- BENCO — BENCO DENTAL SUPPLY CO. · Class II
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- Criterion — HENRY SCHEIN, INC. · Class II
- PRIMED — priMED Medical Products Inc · Class II
- NOVAPLUS — O&M HALYARD, INC. · Class II
- MEDICOM SAFEMASK CLASSICS — AMD Medicom Inc · Class II
- THE SEA — Mexpo International, Inc. · Class II
Cleared under the same submission
K770463 also covers:
- AmerisourceBergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
- AmerisourceBergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
- Precept® — Precept Medical Products, Inc.
- Precept® — Precept Medical Products, Inc.
- Precept® — Precept Medical Products, Inc.
- Precept® — Precept Medical Products, Inc.
- Precept® — Precept Medical Products, Inc.
- Precept® — Precept Medical Products, Inc.
- Precept® — Precept Medical Products, Inc.
- Precept® — Precept Medical Products, Inc.
- Precept® — Precept Medical Products, Inc.
- Precept® — Precept Medical Products, Inc.
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
- Bp Pharmaceuticals Laboratories Unlimited Company
Sources (1)
- FDA UDI 5305792c-014e-4ba6-bfbc-f008229efa02 34 fields · synced May 29, 2026