Identity
- Trade Name
- MedSource Mouthpiece Universal FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- Mouthpiece Universal FDA UDI
- Model / Reference
- MS-22890 FDA UDI
- Description
- Mouthpiece Universal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816703020012 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary resuscitation mask, single-use
MedSource Mouthpiece Universal by Medsource International Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary resuscitation mask, single-use.
- 16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- First Aid Only — Acme United Corporation · Class I
- 10PW - Oklahoma Gas & Electric - Poly White — Certified Safety Manufacturing, Inc. · N
- Rescue Breather — O-Two Medical Technologies Inc · Class I
- EMT - Duke Energy TD - Red Bag — Certified Safety Manufacturing, Inc. · Class II
- ZLB - 10 - Metra 49-980170 — Certified Safety Manufacturing, Inc. · Class II
- FAC-3 - Lawson Class B — Certified Safety Manufacturing, Inc. · N
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medsource International Llc
Sources (1)
- FDA UDI e4c19e3c-a58e-4543-b844-8e997b919b53 33 fields · synced Jun 1, 2026