CTC DVT Sleeve

GUDID 10861317020337

VasoGrad Lg Calf 24in. Sleeve

RENU MEDICAL, INC

Multi-chamber venous compression system garment, reprocessed
Primary Device ID10861317020337
NIH Device Record Key68ec27f9-41b2-4152-a4a2-cadf83209a9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCTC DVT Sleeve
Version Model NumberRM-VG-501L
Company DUNS100439103
Company NameRENU MEDICAL, INC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100861317020330 [Primary]
GS110861317020337 [Package]
Contains: 00861317020330
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSleeve, Limb, Compressible

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-23

On-Brand Devices [CTC DVT Sleeve]

00861317022952VasoGrad Medium Thigh 29in. Sleeve
10861317022942VasoGrad Lg Thigh 36in. Sleeve
10861317020436VasoPress Medium Thigh 29in. Sleeve
10861317020429VasoPress Lg Thigh 36in. Sleeve
10861317020412VasoPress VP520L Foot
10861317020405VasoPress Foot R or L
10861317020399VasoPress Medium Calf 18in. Sleeve - Green
10861317020382VasoPress Medium Calf 18in. Sleeve
10861317020375VasoPress Lg Calf 24in. Sleeve - Green
10861317020368VasoPress Lg Calf 24in. Sleeve
10861317020351VasoPress Calf 32in. Sleeve
10861317020344VasoGrad Medium Calf 18in. Sleeve
10861317020337VasoGrad Lg Calf 24in. Sleeve
00816317022952VasoGrad Medium Thigh 29in. Sleeve
10816317022942VasoGrad Lg Thigh 36in. Sleeve
10816317020436VasoPress Medium Thigh 29in. Sleeve
10816317020429VasoPress Lg Thigh 36in. Sleeve
10816317020412VasoPress VP520L Foot
10816317020405VasoPress Foot R or L
10816317020399VasoPress Medium Calf 18in. Sleeve - Green
10816317020382VasoPress Medium Calf 18in. Sleeve
10816317020375VasoPress Lg Calf 24in. Sleeve - Green
10816317020368VasoPress Lg Calf 24in. Sleeve
10816317020351VasoPress Calf 32in. Sleeve
10816317020344VasoGrad Medium Calf 18in. Sleeve
10816317020337VasoGrad Lg Calf 24in. Sleeve

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