Identity
- Trade Name
- DISPOSABLE BEDDING PRODUCTS FDA UDI
- Generic Name
- Foam-filled bed mattress overlay FDA UDI
- Device Name
- MEDICAL DISPOSABLE BEDDING, PROTECT BEDDING FROM GETTING STAINED DURING USE, PROTECT PATIENT FROM CROSS-INFECTION CAUSED BY BEDDING FDA UDI
- Model / Reference
- 28020 FDA UDI
- Description
- MEDICAL DISPOSABLE BEDDING, PROTECT BEDDING FROM GETTING STAINED DURING USE, PROTECT PATIENT FROM CROSS-INFECTION CAUSED BY BEDDING FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06950471300038 FDA UDI
- FDA Product Code
- KME FDA UDI
- GMDN Term
- Foam-filled bed mattress overlay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6060 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foam-filled bed mattress overlay
Disposable Bedding Products by Hangzhou A-Tek Medical & Textiles Co., Ltd. — 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
- Hangzhou A-Tek Medical & Textiles Co., Ltd.
Sources (1)
- FDA UDI 6630e93f-07f9-4cf0-a3ca-595ba30edb6d 33 fields · synced Jun 6, 2026