FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50192253057780
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
9529R
Catalog number
9529R
Device description
Kendall SCD Express Sleeves, Knee Length, Medium
Published
2025-05-07
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
true

Product Codes#

Code, Name table
CodeName
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253057780PackageGS15In Commercial Distribution
10192253057782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225305778050192253057780
1019225305778210192253057782

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719893351026WellellWellell Inc.JOW2026-03-17
00812311022363BIOARTERIAL+Bio Compression Systems, IncJOW2026-03-09
00850033615272ThermoTek WRAP, DVT, CALF SET, PUSH, SPUTHERMOTEK, INC.JOW2026-02-21
00850033615494ThermoTek WRAP,DVT,CA,SET,PUSH,SPU, QTY 10, CTNTHERMOTEK, INC.JOW2026-02-21
00812311022479Bio Arterial DeluxeBio Compression Systems, IncJOW2026-02-13
00850001096386Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096393Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096409Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096416Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096423Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096430Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096447Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096461Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096478Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096485Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096492Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096508Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096522Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096539Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096546Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096553Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
10885380185120KendallCardinal Health 200, LLCJOW2026-02-10
18809802648491DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
18809802648507DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
10816317024427Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
10816317024434Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
10816317024441Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
00850031012615AIROSAIROS MEDICAL INCJOW2026-01-23
10850031012629AIROSAIROS MEDICAL INCJOW2026-01-23
10850031012636AIROSAIROS MEDICAL INCJOW2026-01-23