Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Public face mask, single-use FDA UDI
- Device Name
- MASK,TIE,PURP,DKBILL,SHIELD,FOAM,LVL 3 FDA UDI
- Model / Reference
- NON27010 FDA UDI
- Description
- MASK,TIE,PURP,DKBILL,SHIELD,FOAM,LVL 3 FDA UDI
Identifiers
- Catalog Number
- NON27010 FDA UDI
- Primary DI / UDI-DI
- 20197344101778 FDA UDI
- 510(k) Number
- K223236 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Public face mask, 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Category: Public face mask, single-use
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Trinity Sterile, Inc. — TRINITY STERILE, INC. · N
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- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC · Class II
Cleared under the same submission
K223236 also covers:
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI bfbee6b3-3d0f-4022-a146-e90495d74a98 37 fields · synced May 30, 2026