Identity
- Trade Name
- MedSource Face Mask FDA UDI
- Generic Name
- Aerosol face mask, rebreathing, single-use FDA UDI
- Device Name
- Face Mask, Padded, Toddler, Ambu FDA UDI
- Model / Reference
- MS-21133 FDA UDI
- Description
- Face Mask, Padded, Toddler, Ambu FDA UDI
Identifiers
- Catalog Number
- Not Applicable FDA UDI
- Primary DI / UDI-DI
- 00816703025888 FDA UDI
- FDA Product Code
- QKR FDA UDI
- GMDN Term
- Aerosol face mask, rebreathing, single-use FDA UDI
Classification
- Device Class
- N 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Aerosol face mask, rebreathing, single-use
MedSource Face Mask by Medsource International Llc — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aerosol face mask, rebreathing, single-use.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- Oxygen Masks — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Procure — Twin Med, LLC · Class I
- Easivent Mask - Small — Mylan Specialty L.P. · Class II
- System 22 — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class I
- System 22 — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
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 N | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medsource International Llc
Sources (1)
- FDA UDI 28a718b5-ba61-46d4-81fe-7a5e12382e91 34 fields · synced May 30, 2026