Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- RESUSCITATOR,MANL,ADT,MASK,BAG RES,MANO FDA UDI
- Model / Reference
- CPRM1116M FDA UDI
- Description
- RESUSCITATOR,MANL,ADT,MASK,BAG RES,MANO FDA UDI
Identifiers
- Catalog Number
- CPRM1116M FDA UDI
- Primary DI / UDI-DI
- 10888277628304 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 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
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: Pulmonary resuscitator, manual, single-useResuscitator face mask, single-use
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Resuscitator face mask, single-use.
- Top Safety — FOREMOUNT ENTERPRISE CO., LTD. · Class II
- Top Safety — FOREMOUNT ENTERPRISE CO., LTD. · Class II
- KIEFER — FOREMOUNT ENTERPRISE CO., LTD. · Class II
- WNL — FOREMOUNT ENTERPRISE CO., LTD. · Class II
- Top Safety — FOREMOUNT ENTERPRISE CO., LTD. · Class II
- Rescuer Disposable Resuscitation Cushion Mask (#1 Infant) — B.L.S. Systems Limited · Class I
- WorldPoint — FOREMOUNT ENTERPRISE CO., LTD. · Class II
- Top Safety — FOREMOUNT ENTERPRISE CO., LTD. · Class II
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 851704cb-88cd-467e-a5cd-bd4178afa481 35 fields · synced Jun 6, 2026