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) (10)

Premarket Exempt

No Yes

Clear

Bosma Enterprises - 00818634020727 Catalog Number : 10-8020DNL

Device Description : Accelerate-OR Lithotomy DNL Kit; Each Kit Includes Lithotomy Suite Kit, 40x60 Sa Accelerate-OR Lithotomy DNL Kit; Each Kit Includes Lithotomy Suite Kit, 40x60 Sahara OR Table Sheet 20" Absorb, and 4x60 Foam Positioning Strap.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020734 Catalog Number : 10-8020DCL

Device Description : Accelerate-OR Lithotomy Suite DCL Kit; Each Kit Includes Lithotomy Suite Kit, 40 Accelerate-OR Lithotomy Suite DCL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), 40x40 Red Infectious Waste 2 mil Draw Tape Bag (2), 4x60 Foam Positioning Strap, and Disposable Microfiber Mop Head.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020741 Catalog Number : 10-8020HUL

Device Description : Accelerate-OR Lithotomy Suite HUL Kit; Each Kit Includes Lithotomy Suite Kit, 40 Accelerate-OR Lithotomy Suite HUL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), and Disposable Microfiber Mop Head.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020758 Catalog Number : 10-8020LRC

Device Description : Accelerate-OR Cath & EP LRC Kit; Each Kit Includes QuickSuite Kit, 60x78 Patient Accelerate-OR Cath & EP LRC Kit; Each Kit Includes QuickSuite Kit, 60x78 Patient Lift Sheet, 40x60 Sahara OR Table Sheet 20" Absorb, and Armboard Covers with Integrated Straps.

Device Class :

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020765 Catalog Number : 10-8020MU

Device Description : Accelerate-OR Lithotomy Suite MU Kit; Each Kit Includes Lithotomy Suite Kit, 40x Accelerate-OR Lithotomy Suite MU Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag, 40x40 Red Infectious Waste 2 mil Draw Tape Bag, 40x40 Blue 2 mil Draw Tape Bag, and 24x24 Red Liner 1.2 mil 10 gal Bag (2).

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020772 Catalog Number : 10-8020ORL

Device Description : Accelerate-OR Cysto ORL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear Accelerate-OR Cysto ORL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag (2), 24x24 Red Liner 1.2 mil 10 gal Bag, Non-sterile Drain Bag Pouch, 4x60 Foam Positioning Strap, and MicroMax Microfiber Mop Head 18" w/ Scrubber Strips.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020789 Catalog Number : 10-8020SAL

Device Description : Accelerate-OR Lithotomy Suite SAL Kit; Each Kit Includes Lithotomy Suite Kit, 40 Accelerate-OR Lithotomy Suite SAL Kit; Each Kit Includes Lithotomy Suite Kit, 40x40 Clear 2 mil Draw Tape Bag, 24x32 Clear Liner 1 mil 15 gal Bag (2), 38x41 Blue Liner 2.5 mil Bag (2), Disposable Washcloth (4), and Disposable Microfiber Mop Head.

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020796 Catalog Number : 10-8020SEL

Device Description : Accelerate-OR Lithotomy Suite SEL Kit; Each Kit Includes Lithotomy Suite Kit, 40 Accelerate-OR Lithotomy Suite SEL Kit; Each Kit Includes Lithotomy Suite Kit, 40x60 Sahara OR Table Sheet 20" Absorb, 40x40 Red Infectious Waste 2 mil Draw Tape Bag, 40x40 Blue 2 mil Draw Tape Bag, 38x38 Clear 1.5 mil Draw Cord Bag (4), 24x24 Red Liner 1.2 mil 10 gal Bag (2), and Disposable Washcloth (6).

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020802 Catalog Number : 10-8020SED

Device Description : Accelerate-OR Dental SED Kit; Each Kit Includes 40x40 Red Infectious Waste 2 mil Accelerate-OR Dental SED Kit; Each Kit Includes 40x40 Red Infectious Waste 2 mil Draw Tape Bag, 40x40 Blue 2 mil Draw Tape Bag, 38x38 Clear 1.5 mil Draw Cord Bag (4) and 24x24 Red Liner 1.2 mil 10 gal Bag (2).

Device Class : 1

Duns Number: 878070325

Premarket Exempt : Yes

Product Code : PWU

Prescription Use : No

Device Count : 1

Bosma Enterprises - 00818634020819 Catalog Number : 10-9030DC

Device Description : Ambulance Pack Washington DC Kit; Each Kit Includes 40x80 Disposable Grey Poly B Ambulance Pack Washington DC 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

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