Identity
- Trade Name
- K-3 AIRE-ZONE FDA UDI
- Generic Name
- Low-air-loss bed FDA UDI
- Device Name
- Pulsation, True Low Air Loss 8" High, 80"~85"~90" Variable Length Mattress, Standard EU System FDA UDI
- Model / Reference
- K-3-EU-VL-MS-8 FDA UDI
- Description
- Pulsation, True Low Air Loss 8" High, 80"~85"~90" Variable Length Mattress, Standard EU System FDA UDI
Identifiers
- Catalog Number
- K-3-EU-VL-MS-8 FDA UDI
- Primary DI / UDI-DI
- 00817012025118 FDA UDI
- FDA Product Code
- IOQ FDA UDI
- GMDN Term
- Low-air-loss bed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5170 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-3 Aire-Zone by Kap Medical — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Kap Medical
Sources (1)
- FDA UDI 9f1e3ae4-24eb-4d9d-a80b-25ac16128978 35 fields · synced May 31, 2026