Identity
- Trade Name
- Bosma Enterprises FDA UDI
- Generic Name
- Pillow cover, single-use FDA UDI
- Device Name
- Patient Transportation PTB Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Gurney Sheet with Elastic at the Head and Foot, 34x66 Disposable Standard Draw Sheet, and STAT-BLOC Disposable Pillowcase. FDA UDI
- Model / Reference
- 10-9030PTB FDA UDI
- Description
- Patient Transportation PTB Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Gurney Sheet with Elastic at the Head and Foot, 34x66 Disposable Standard Draw Sheet, and STAT-BLOC Disposable Pillowcase. FDA UDI
Identifiers
- Catalog Number
- 10-9030PTB FDA UDI
- Primary DI / UDI-DI
- 00818634020284 FDA UDI
- FDA Product Code
- PWU FDA UDI
- GMDN Term
- Pillow cover, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6890 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic bed sheet, single-usePillow cover, single-use
Bosma Enterprises by Bosma Enterprises — 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
- Bosma Enterprises
Sources (1)
- FDA UDI ef5a7d3b-85c4-4d56-bd40-93c59395de6f 36 fields · synced May 30, 2026