BAROVAC® Evacuator Closed Wound Drainage System(PS)

GUDID 08806369477864

Sewoon Medical Co., Ltd.

Closed-wound drainage kit
Primary Device ID08806369477864
NIH Device Record Keyec91a612-dfd7-42be-a00d-59fed742879d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBAROVAC® Evacuator Closed Wound Drainage System(PS)
Version Model NumberPS200C2(3.2)
Company DUNS687784405
Company NameSewoon Medical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806369477864 [Primary]

FDA Product Code

GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-04
Device Publish Date2023-07-27

On-Brand Devices [BAROVAC® Evacuator Closed Wound Drainage System(PS)]

08806369477864PS200C2(3.2)
08806369455008PS800L(4.8)
08806369454582PS400JP(4.8)
08806369454568PS400L+(4.8)
08806369454544PS400L(4.8)
08806369454520PS400M+(3.2)
08806369454506PS400M(3.2)
08806369454025PS200M(3.2)
08806369454001PS200C(3.2)

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