Identity
- Trade Name
- K-6oem AIRE-TURN FDA UDI
- Generic Name
- Low-air-loss bed FDA UDI
- Device Name
- Alternating Pressure Lateral Rotation with On-Demand Low Air Loss Expandable Mattress System 80"-84"-88" x 36"-42"-48" x 10" FDA UDI
- Model / Reference
- U-K-6oemXMS FDA UDI
- Description
- Alternating Pressure Lateral Rotation with On-Demand Low Air Loss Expandable Mattress System 80"-84"-88" x 36"-42"-48" x 10" FDA UDI
Identifiers
- Catalog Number
- U-K-6oemXMS FDA UDI
- Primary DI / UDI-DI
- 00817012022285 FDA UDI
- FDA Product Code
- IKZ FDA UDI
- GMDN Term
- Low-air-loss bed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5225 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
Yes
FDA UDI
Category: Low-air-loss bed
K-6oem AIRE-TURN by Kap Medical — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kap Medical
Sources (2)
- FDA UDI dc592aae-fdbc-46e9-a6c2-700883b501bb 34 fields · synced Jun 8, 2026
- EUDAMED 1 fields · synced May 22, 2026