FDA.reportPublic FDA data

NA

Primary DI
04719873695669
Brand
NA
Company
CARILEX MEDICAL, INC.
Model
S1004-6030
Device description
Canister for VT• One - 150ml luer lock
Published
2021-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873695676PackageGS15Not in Commercial Distribution
04719873695683PackageGS18Not in Commercial Distribution
14719873695666PackageGS15In Commercial Distribution
24719873695663PackageGS110In Commercial Distribution
04719873695669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873695676047198736956764719873695676
04719873695683047198736956834719873695683
1471987369566614719873695666
2471987369566324719873695663
04719873695669047198736956694719873695669

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system canisterA receptacle for the collection of excess interstitial fluid, exudate, and infectious materials from a dedicated dressing that has been applied for a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT). It is typically made of transparent disposable plastic materials and is connected to or placed into the NPWT system's vacuum pump. This receptacle is a single-use device that should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill).

Regulatory Flags#

DUNS number
658863238
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873698622NAS2003-A3002025-12-22
04719873698639NAS2003-A3102025-12-22
04719873698608NAS2003-22502025-12-22
04719873698615NAS2003-22602025-12-22
14719873698629NAS2003-A3002025-12-22
14719873698636NAS2003-A3102025-12-22
04713616090230NAS1001-20502018-12-05
04713616090247NAS1001-20602018-11-28
04713616091336NAS1001-21002021-03-16
04713616091350NAS1001-21302018-06-12
04713616091381NAS1001-21402018-06-12
04713616091411NAS1001-21502018-06-12
04713616092906NAS1001-20202018-06-12
04713616092913NAS1001-20302018-06-12
04713616094597NAS1001-81602021-03-16
04713616094627NAS1001-82002021-03-16
04719873691241NAS1001-21202018-12-05
04719873694938NAS1001-21602020-12-18
04719873694969NAS1001-21702020-12-14
04719873694990NAS1001-21802020-12-18

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Primary DI, Brand, Company table
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