Bosma Enterprises

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Clean-Up Kit (PWU) (9) Splint, Extremity, Non-Inflatable, External, Non-Sterile (NOC) (1)

Premarket Exempt

No Yes

Clear

Kay Kare - 00818634020017 Catalog Number : 10-30105 DS

Device Description : Kay Kare Brace Kit; Each Kit Includes Disposable Multi Purpose Wrap, and 35x4.25 Kay Kare Brace Kit; Each Kit Includes Disposable Multi Purpose Wrap, and 35x4.25 Flat SAM Splint.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020222 Catalog Number : 10-8020BAO

Device Description : Accelerate-OR BAO Kit; Each Kit Includes QuickSuite Kit, 40x40 Clear 2 mil Draw Accelerate-OR BAO Kit; Each Kit Includes QuickSuite Kit, 40x40 Clear 2 mil Draw Tape Bag, 40x40 Red Infectious Waste 2 mil Draw Tape Bag (3), 24x24 Red Liner 1.2 mil 10 gal Bag (2), Disposable Washcloth (2), 4x60 Foam Positioning Strap and Disposable Microfiber Mop Head.

Device Class :

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020239 Catalog Number : 10-9030PTL

Device Description : Ambulance Pack PTL Kit; Each Kit Includes STAT-BLOC Disposable Antimicrobial Imp Ambulance Pack PTL Kit; Each Kit Includes STAT-BLOC Disposable Antimicrobial Impervious Fitted Gurney Sheet, 34x66 Disposable Standard Draw Sheet, and STAT-BLOC Disposable Pillowcase.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020246 Catalog Number : 10-9030PTP

Device Description : Ambulance Pack PTP Kit; Each Kit Includes STAT-BLOC Antimicrobial Impervious Fit Ambulance Pack PTP Kit; Each Kit Includes STAT-BLOC Antimicrobial Impervious Fitted Gurney Sheet, and 34x66 Disposable Standard Draw Sheet.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020253 Catalog Number : 10-9030JBE

Device Description : Ambulance Pack JBE Kit; Each Kit Includes 70x90 Unbleached Blanket, and Sahara O Ambulance Pack JBE Kit; Each Kit Includes 70x90 Unbleached Blanket, and Sahara OR Table Sheet and Draw/Lift Sheet.

Device Class :

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020260 Catalog Number : 10-9030

Device Description : Ambulance Pack Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 40x80 Ambulance Pack Kit; Each Kit Includes 40x80 Disposable Grey Poly Blanket, 40x80 Disposable XL Lift Sheet, Disposable Short Sleeve Blue Isolation Gown 3X and 13x17 Disposable Pillow.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020277 Catalog Number : 10-9030BAL

Device Description : Patient Transportation BAL Kit; Each Kit Includes STAT-BLOC Disposable Premium A Patient Transportation BAL Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Wide Gurney Sheet with Elastic at the Head and Foot, 40x80 XL Lift Sheet, and STAT-BLOC Disposable Pillowcase.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020284 Catalog Number : 10-9030PTB

Device Description : Patient Transportation PTB Kit; Each Kit Includes STAT-BLOC Disposable Premium A 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.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020291 Catalog Number : 10-9030PTC

Device Description : Patient Transportation PTC Kit; Each Kit Includes STAT-BLOC Disposable Premium A Patient Transportation PTC Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Gurney Sheet with Elastic at the Head and Foot, 60x80 XXL Lift Sheet, 34x66 Disposable Standard Draw Sheet, and STAT-BLOC Disposable Pillowcase.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020307 Catalog Number : 10-9030PTT

Device Description : Patient Transportation PTT Kit; Each Kit Includes STAT-BLOC Disposable Premium A Patient Transportation PTT Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Partially-Fitted Gurney Sheet, 34x66 Disposable Standard Draw Sheet, and STAT-BLOC Disposable Pillowcase.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

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