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Unomedical, Mouth to Mask Resuscitator with Filter Adult Mask
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Unomedical, Mouth to Mask Resuscitator with Filter Adult Mask FDA UDI
- Generic Name
- Resuscitator face mask, single-use FDA UDI
- Device Name
- Unomedical, Mouth to Mask Resuscitator with Filter Adult Mask FDA UDI
- Model / Reference
- 1058MM FDA UDI
- Description
- Unomedical, Mouth to Mask Resuscitator with Filter Adult Mask FDA UDI
Identifiers
- Catalog Number
- 1058MM FDA UDI
- Primary DI / UDI-DI
- 00084424900061 FDA UDI
- 510(k) Number
- K873286 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Resuscitator face mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Unomedical, Mouth to Mask Resuscitator with Filter Adult Mask by Convatec, Purchasing Department — Class II — FDA UDI — listed in FDA GUDID
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
- Convatec, Purchasing Department
Sources (1)
- FDA UDI bd6310f6-2b23-415e-bd72-cdf0e60cc05e 36 fields · synced May 31, 2026