Identity
- Trade Name
- Bosma Enterprises FDA UDI
- Generic Name
- Operating room turnover kit FDA UDI
- Device Name
- Accelerate-OR RIO Kit; Each Kit Includes QuickSuite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), 40x40 Red Infectious Waste 2 mil Draw Tape Bag, 40x40 Blue 2 mil Draw Tape Bag, 24x24 Red Liner 1.2 mil 10 gal Bag (2), Disposable Washcloth (2), 4x60 Foam Positioning Strap, 20x29 Disposable Pillowcase (4), and Disposable Microfiber Mop Head. FDA UDI
- Model / Reference
- 10-8020RIO FDA UDI
- Description
- Accelerate-OR RIO Kit; Each Kit Includes QuickSuite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), 40x40 Red Infectious Waste 2 mil Draw Tape Bag, 40x40 Blue 2 mil Draw Tape Bag, 24x24 Red Liner 1.2 mil 10 gal Bag (2), Disposable Washcloth (2), 4x60 Foam Positioning Strap, 20x29 Disposable Pillowcase (4), and Disposable Microfiber Mop Head. FDA UDI
Identifiers
- Catalog Number
- 10-8020RIO FDA UDI
- Primary DI / UDI-DI
- 00818634020659 FDA UDI
- FDA Product Code
- PWU FDA UDI
- GMDN Term
- Operating room turnover kit 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: Limb/torso/head restraint, single-useOperating room turnover kitSurgical linen/cushion setBucket liner
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 a14725ae-79d6-49d7-a0a2-7d44f326f8b9 36 fields · synced Jun 6, 2026