SOMAVAC MEDICAL SOLUTIONS, INC.

Address:3144 Stage Post Drive,Memphis,TN,38133,US

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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

Apparatus, Suction, Single Patient Use, Portable, Nonpowered (GCY) (8) Pump, Portable, Aspiration (Manual Or Powered) (BTA) (2)

Premarket Exempt

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SOMAVAC 100 Vacuum Source - 00850004219010 Catalog Number : 20011

Device Description : Portable battery powered vacuum source at 100mmHg

Device Class : 1

Duns Number: 080446796

Premarket Exempt : No

Product Code : GCY, BTA

Prescription Use : Yes

Device Count : 1

SOMAVAC 100 Sustained Vacuum System - 00850004219027 Catalog Number : 10011

Device Description : Portable, battery powered vacuum source with waste containers and accessories.

Device Class : 1

Duns Number: 080446796

Premarket Exempt : No

Product Code : GCY, BTA

Prescription Use : Yes

Device Count : 1

SOMAVAC Drain Connector - 00850004219034 Catalog Number : 20031

Device Description : Filter and check valve; one end barb, one end Luer.

Device Class :

Duns Number: 080446796

Premarket Exempt : No

Product Code : GCY

Prescription Use : Yes

Device Count : 1

SOMAVAC Waste Collection Unit - 00850004219041 Catalog Number : 20021

Device Description : Disposable waste collection unit for SOMAVAC Sustained Vacuum System with 100cc Disposable waste collection unit for SOMAVAC Sustained Vacuum System with 100cc total capacity.

Device Class :

Duns Number: 080446796

Premarket Exempt : No

Product Code : GCY

Prescription Use : Yes

Device Count : 1

SOMAVAC Belt - 00850004219058 Catalog Number : 20041

Device Description : Belt for SOMAVAC Sustained Vacuum System; 25-50in.

Device Class :

Duns Number: 080446796

Premarket Exempt : No

Product Code : GCY

Prescription Use : Yes

Device Count : 1

SOMAVAC Belt Extender - 00850004219065 Catalog Number : 20051

Device Description : Extender for SOMAVAC Belt, 80 in.

Device Class : 1

Duns Number: 080446796

Premarket Exempt : No

Product Code : GCY

Prescription Use : Yes

Device Count : 1

SOMAVAC Drain Connector - Dual Input - 00850004219072 Catalog Number : 10061

Device Description : Somavac Drain Connector with two inputs and a single output.

Device Class : 1

Duns Number: 080446796

Premarket Exempt : No

Product Code : GCY

Prescription Use : Yes

Device Count : 1

SOMAVAC Drain Connector - Dual Output - 00850004219096 Catalog Number : 10081

Device Description : Sterile Drain Connector with a single input and two outputs.

Device Class :

Duns Number: 080446796

Premarket Exempt : No

Product Code : GCY

Prescription Use : Yes

Device Count : 1

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