FDA.reportPublic FDA data

BAROVAC® Evacuator Closed Wound Drainage System(SS)

Primary DI
08806369452021
Brand
BAROVAC® Evacuator Closed Wound Drainage System(SS)
Company
Sewoon Medical Co., Ltd.
Model
SS100M+(3.2)
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806369452021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806369452021088063694520218806369452021

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, kit, rapid spectrophotometry, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of ethyl alcohol (ETOH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid spectrophotometry method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to assess for alcohol intoxication and in the management of alcoholism. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687784405
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806369400220BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200M2+(3.2)2023-07-27
08806369400244BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200L2+(4.8)2023-07-27
08806369427333BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100M(3.2)S2023-07-27
08806369427371BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200M(3.2)S2023-07-27
08806369427418BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200L(4.8)S2023-07-27
08806369427456BAROVAC® Evacuator Closed Wound Drainage System(SS)SS200L+(4.8)S2023-07-27
08806369427494BAROVAC® Evacuator Closed Wound Drainage System(SS)PS400L(4.8)S2023-07-27
08806369427616BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400M(3.2)N2732023-07-27
08806369427654BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400L(4.8)N2732023-07-27
08806369427692BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400S(2.4)2023-07-27
08806369427739BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400M(3.2)S2023-07-27
08806369427777BAROVAC® Evacuator Closed Wound Drainage System(PP)PP400L(4.8)S2023-07-27
08806369452007BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100M(3.2)2023-07-27
08806369452045BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100L(4.8)2023-07-27
08806369452069BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100L+(4.8)2023-07-27
08806369452083BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100LD(4.8)2023-07-27
08806369452106BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100JP(4.8)2023-07-27
08806369452120BAROVAC® Evacuator Closed Wound Drainage System(SS)SS100M2(3.2)2023-07-27
08806369452526BAROVAC® Evacuator Closed Wound Drainage System(SS)SS150M+(3.2)2023-07-27
08806369452564BAROVAC® Evacuator Closed Wound Drainage System(SS)SS150L+(4.8)2023-07-27

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Primary DI, Brand, Company table
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10198956012769CARDINAL HEALTHCardinal Health 200, LLCGCY2025-03-26
10197106675588CARDINAL HEALTHCardinal Health 200, LLCGCY2024-05-22
10197106600788CARDINAL HEALTHCardinal Health 200, LLCGCY2024-03-25
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