SOMAVAC 100 Sustained Vacuum System 10011

GUDID 00850004219027

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

SOMAVAC MEDICAL SOLUTIONS, INC.

Closed-wound drainage suction pump
Primary Device ID00850004219027
NIH Device Record Key6039a784-bcd1-49b0-b401-2a8b9ae751e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOMAVAC 100 Sustained Vacuum System
Version Model Number10011
Catalog Number10011
Company DUNS080446796
Company NameSOMAVAC MEDICAL SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004219027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-09
Device Publish Date2019-08-30

Devices Manufactured by SOMAVAC MEDICAL SOLUTIONS, INC.

10850004219079 - SOMAVAC Drain Connector - Dual Input2020-12-28 Somavac Drain Connector with two inputs and a single output.
00850004219096 - SOMAVAC Drain Connector - Dual Output2020-12-28 Sterile Drain Connector with a single input and two outputs.
00850004219041 - SOMAVAC Waste Collection Unit2020-05-06 Disposable waste collection unit for SOMAVAC Sustained Vacuum System with 100cc total capacity.
00850004219034 - SOMAVAC Drain Connector2020-01-01 Filter and check valve; one end barb, one end Luer.
00850004219058 - SOMAVAC Belt2019-12-11 Belt for SOMAVAC Sustained Vacuum System; 25-50in.
10850004219062 - SOMAVAC Belt Extender2019-12-11 Extender for SOMAVAC Belt, 80 in.
00850004219010 - SOMAVAC 100 Vacuum Source2019-09-09 Portable battery powered vacuum source at 100mmHg
00850004219027 - SOMAVAC 100 Sustained Vacuum System2019-09-09Portable, battery powered vacuum source with waste containers and accessories.
00850004219027 - SOMAVAC 100 Sustained Vacuum System2019-09-09 Portable, battery powered vacuum source with waste containers and accessories.

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