FDA.reportPublic FDA data

Medline ReNewal

Primary DI
10888277355330
Brand
Medline ReNewal
Company
MEDLINE INDUSTRIES, INC.
Model
REP115683
Catalog number
REP115683
Device description
MDS630BSQ VASO-FORCE SEQUENTIAL SLEEVE,
Published
2016-10-14
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
true

Contact Domains#

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
10888277355330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827735533010888277355330

GMDN Terms#

Term, Definition table
TermDefinition
Single-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 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 previously used single-use device that has been processed for an additional single-use patient application.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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