Bio Compression Systems 4 Chamber Wide Leg Medium

GUDID 00812311020987

Bio Compression Systems, Inc

Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable
Primary Device ID00812311020987
NIH Device Record Key3957f91f-292a-4b13-b0fc-5c4fb5a9f0a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio Compression Systems 4 Chamber Wide Leg Medium
Version Model NumberGW-3045-M
Company DUNS101393924
Company NameBio Compression Systems, Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
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
GS100812311020987 [Primary]

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 Number6
Public Version Date2020-01-29
Device Publish Date2017-12-11

On-Brand Devices [Bio Compression Systems 4 Chamber Wide Leg Medium]

00812311020987GW-3045-M
00812311022219GW-3045-M-BT

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