FDA.reportPublic FDA data

DVT

Primary DI
05690977445246
Brand
DVT
Company
OSSUR AMERICAS, INC.
Model
MDSDVT62201
Catalog number
MDSDVT62201
Device description
CA5 LARGE CUFF-MEDLINE
Published
2018-05-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K061125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061125000DVTCARE CA5Doctors Orders2006-05-23JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05690977445246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05690977445246056909774452465690977445246

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
139280028
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05690967529864Rheo KneeRKN12100RKN121002018-05-16
05690967566227Rheo KneeRKNLPCWB1RKNLPCWB12018-05-16
05690967595418Rheo KneeRKN130003RKN1300032018-05-16
05690967596644Rheo KneeRKN13100RKN131002018-05-16
05690967598426Rheo KneeRKN130002RKN1300022018-05-16
05690967598433Rheo KneeRKN130005RKN1300052018-05-16
05690967600587Rheo KneeRKN13110RKN131102018-05-16
05690967600594Rheo KneeRKN13210RKN132102018-05-16
05690967610517Rheo KneeRKN13140RKN131402018-05-16
05690967613136Rheo KneeRKN13130RKN131302018-05-16
05690977279728Rheo KneeRKN13240RKN132402018-05-16
05690977467798Rheo KneeRKNXC0002RKNXC00022018-05-16
05690977467804Rheo KneeRKNXC0003RKNXC00032018-05-16
05690977467811Rheo KneeRKNXC0005RKNXC00052018-05-16
05690977467873Rheo KneeRKNXC230RKNXC2302018-05-16
05690967648749Power KneePKA10003PKA100032022-07-08
05690967642822Power KneePKA01001LPKA01001L2021-03-12
05690967642839Power KneePKA01001TPKA01001T2021-03-12
05690967648381Power KneePKA10001PKA100012021-03-12
05690967648404Power KneePKA10002PKA100022021-03-12

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