FDA.report

Kendall

Primary DI
10885380194597
Brand
Kendall
Company
Cardinal Health 200, LLC
Model
83022B
Catalog number
83022B
Device description
KENDALL SCD Express Sleeves. This product is designed for use with KENDALL SCD SMARTFLOW Controller. Knee Length Medium Single Patient Use. Kit Contents: 83022 and/or 83022R. May Contain OEM and/or Reprocessed Devices. Exposed to EO Gas. Reprocessed Device for Single Patient Use Reprocessed by Sustainable Technologies.
Published
2025-03-07
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
50885380194595PrimaryGS10
10885380194597Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088538019459550885380194595
1088538019459710885380194597

GMDN Terms

TermDefinition
Multi-chamber venous compression system garment, reprocessedA non-sterile 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 sequential inflation of several chambers. 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 previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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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