FDA.report

NA

Primary DI
04713616092012
Brand
NA
Company
CARILEX MEDICAL, INC.
Model
S1004-0012
Device description
VT．One SYS Global Carilex
Published
2017-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications

CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04713616092012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04713616092012047136160920124713616092012

GMDN Terms

TermDefinition
Negative-pressure wound therapy system pump, electricA mains electricity (AC-powered) device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. It is typically a computer-controlled vacuum pump with controls and display for continuous or intermittent negative pressure delivered through a tubing set to the open-cell foam dressing located at the airtight-sealed wound. It typically has internal batteries that allow the device to operate for a short period without line power (e.g., during transport or a power outage).

Sterilization Methods

Method

Regulatory Flags

DUNS number
658863238
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04719873698608NAS2003-22502025-12-22
04719873698615NAS2003-22602025-12-22
14719873698629NAS2003-A3002025-12-22
14719873698636NAS2003-A3102025-12-22
04719873693634NAS1001-21302018-06-12
04719873693641NAS1001-21402018-06-12
04719873693658NAS1001-21502018-06-12
04719873698424NAS2303-70202025-09-09
04719873698431NAS2103-20702025-09-09
14719873698445NAS2103-A0502025-09-09
14719873695741NAS1001-81902025-09-05
14719873695987NAS1001-82202025-09-05
14719873698216NAS2106-A0102025-08-20
04719873698332NAS2109-30112025-08-20
04719873698349NAS2109-20102025-08-20
04719873698356NAS2109-20202025-08-20
04719873698363NAS2109-20302025-08-20
04719873698370NAS2109-20402025-08-20
14719873698384NAS2109-A0102025-08-20
14719873698391NAS2109-A0202025-08-20

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