FDA.reportPublic FDA data

Covidien DVT Sleeve

Primary DI
00816317023232
Brand
Covidien DVT Sleeve
Company
RENU MEDICAL, INC
Model
RM-5489
Device description
Kendall SCD - Lg Knee pr
Published
2017-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031559000RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVESRenu Medical, Inc.2003-11-12JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816317023239PackageGS15In Commercial Distribution
00816317023232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081631702323910816317023239
00816317023232008163170232328163170232320816317023232

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
100439103
Device count
1
DM exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816317024420Kendall DVT SleeveRM-830222026-01-27
00816317024437Kendall DVT SleeveRM-830232026-01-27
00816317024444Kendall DVT SleeveRM-830242026-01-27
10816317024427Kendall DVT SleeveRM-830222026-01-27
10816317024434Kendall DVT SleeveRM-830232026-01-27
10816317024441Kendall DVT SleeveRM-830242026-01-27
00816317024413HoverMatt Lateral Transfer MatRM-HM34SPU-SPLIT-B2025-10-30
00816317023997Nellcor Pulse Oximeter ProbeRM-MAX-P2025-07-08
10816317023994Nellcor Pulse Oximeter ProbeRM-MAX-P2025-07-08
00816317024307Kendall ECG LeadsRM-33136R362025-05-01
00816317024321Kendall ECG LeadsRM-33136RT722025-05-01
00816317024338Kendall ECG LeadsRM-33136RT362025-05-01
00816317024345Kendall ECG LeadsRM-33137T2025-05-01
00816317024352Kendall ECG LeadsRM-331132025-05-01
00816317024369Kendall ECG LeadsRM-33154T2025-05-01
00816317024291Kendall ECG LeadsRM-33114N2025-05-01
10816317024304Kendall ECG LeadsRM-33136R362025-05-01
00816317024314Kendall ECG LeadsRM-33136R722025-05-01
10816317024328Kendall ECG LeadsRM-33136RT722025-05-01
10816317024335Kendall ECG LeadsRM-33136RT362025-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
10193489024531MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
04719893351026WellellWellell Inc.JOW2026-03-17
08809802648494DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802648500DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802646810DVT-2600DAESUNG MAREF CO.,LTD.JOW2025-12-19
08809802646858DVT-4000SDAESUNG MAREF CO.,LTD.JOW2025-12-19
10080196138302MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-14
10193489097252MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-13
10192253057775CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057782CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057799CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057805CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057812CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057829CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10193489003154MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-04-17
10193489003161MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-21
10080196391974MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-18
10197344104543MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-03-11
10192253057768CARDINAL HEALTHCardinal Health 200, LLCJOW2025-02-19
10080196385409MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-01-02
10192253016123Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016130Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016185Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10197344098415MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-12-02
10197344006687MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-11-22
10192253057737CARDINAL HEALTHCardinal Health 200, LLCJOW2024-10-02
10885380184895CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184901CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184918CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25