Identity
- Trade Name
- ProMatt Plus FDA UDI
- Generic Name
- Alternating-pressure bed mattress overlay system FDA UDI
- Device Name
- PROMATT PLUS 90CM MATTRESS DURATUB FDA UDI
- Model / Reference
- PMPE3680SZBADT FDA UDI
- Description
- PROMATT PLUS 90CM MATTRESS DURATUB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810055880898 FDA UDI
- FDA Product Code
- IKY FDA UDI
- GMDN Term
- Alternating-pressure bed mattress overlay system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alternating-pressure bed mattress overlay system
ProMatt Plus by Joerns Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Joerns Healthcare
Sources (1)
- FDA UDI 93885e27-6a91-4d75-be8c-f56d45672ae8 33 fields · synced Jun 9, 2026