Identity
- Trade Name
- Bosma Enterprises FDA UDI
- Generic Name
- Operating room turnover kit FDA UDI
- Device Name
- Accelerate-OR BIO Kit; Each Kit Includes Sahara OR Table and Draw/Lift Sheet, Patient Strap, STAT-BLOC Disposable Antimicrobial Impervious Armboard Cover with Straps (2), 40x40 Clear 2 mil Draw Tape Bag, 40x40 Blue 2 mil Draw Tape Bag, 24x32 Clear Liner 1.0 mil 15 gal Bag (4), 38x47 Buff Color 1.8 mil Waste Bag (3), 18x24 Clear 2 mil 100% Cotton Double Drawstring Bag, Suction Tubing (2), Suction Liner 3000cc (2) and 16 oz Banded Disposable Rayon Mop Head. FDA UDI
- Model / Reference
- 10-8020BIO FDA UDI
- Description
- Accelerate-OR BIO Kit; Each Kit Includes Sahara OR Table and Draw/Lift Sheet, Patient Strap, STAT-BLOC Disposable Antimicrobial Impervious Armboard Cover with Straps (2), 40x40 Clear 2 mil Draw Tape Bag, 40x40 Blue 2 mil Draw Tape Bag, 24x32 Clear Liner 1.0 mil 15 gal Bag (4), 38x47 Buff Color 1.8 mil Waste Bag (3), 18x24 Clear 2 mil 100% Cotton Double Drawstring Bag, Suction Tubing (2), Suction Liner 3000cc (2) and 16 oz Banded Disposable Rayon Mop Head. FDA UDI
Identifiers
- Catalog Number
- 10-8020BIO FDA UDI
- Primary DI / UDI-DI
- 00818634020352 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: Suction/irrigation tubing, single-useLimb/torso/head restraint, single-useOperating room turnover kitPatient transfer/turning sheet, 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 aa508ffc-a948-45b9-9526-8032cad12906 36 fields · synced May 30, 2026