DJO Global DVT Sleeve

GUDID 10816317020030

Aircast VenaFlow Elite Foot Cuff

RENU MEDICAL, INC

Multi-chamber venous compression system garment, reprocessed
Primary Device ID10816317020030
NIH Device Record Keyc0a0202a-7d34-48e5-b277-51fd00aaf2e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDJO Global DVT Sleeve
Version Model NumberRM-3046
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
GS100816317020033 [Primary]
GS110816317020030 [Package]
Contains: 00816317020033
Package: CASE [20 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 Number4
Public Version Date2019-08-02
Device Publish Date2016-08-23

On-Brand Devices [DJO Global DVT Sleeve]

10861317022980Aircast VenaFlow Elite Calf Cuff XL
10861317020030Aircast VenaFlow Elite Foot Cuff
10861317020023Aircast VenaFlow Elite Foam Calf Cuff
10861317020016Aircast VenaFlow Elite Calf Cuff
10861317020009Aircast VenaFlow Calf Cuff
10816317022980Aircast VenaFlow Elite Calf Cuff XL
10816317020030Aircast VenaFlow Elite Foot Cuff
10816317020023Aircast VenaFlow Elite Foam Calf Cuff
10816317020016Aircast VenaFlow Elite Calf Cuff
10816317020009Aircast VenaFlow Calf Cuff

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