FDA.report

CARDINAL HEALTH

Primary DI
10885380107924
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
6700032
Catalog number
6700032
Device description
SVEDMAN Wound Treatment System
Published
2016-07-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

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
10885380107924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088538010792410885380107924

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).

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-12 Degrees Celsius43 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)484-6798xxx@xxx.xxx

Regulatory Flags

DUNS number
961027315
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
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50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

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