FDA.report

A-V Impulse

Primary DI
20192253015932
Brand
A-V Impulse
Company
Cardinal Health 200, LLC
Model
5065
Catalog number
5065-
Device description
5065 IMPAD REGULAR PAIR
Published
2023-12-06
Public version status
New
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
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications

CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20192253015932PackageGS14In Commercial Distribution
50192253015933PackageGS116In Commercial Distribution
10192253015935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225301593220192253015932
5019225301593350192253015933
1019225301593510192253015935

GMDN Terms

TermDefinition
Single-chamber venous compression system garment, single-useAn inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the intermittent inflation of a single-chamber. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a single-use device.

Sterilization Methods

Method

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

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