Bio Compression Systems 4 Chamber Adjustable Extra Wide Leg

GUDID 00812311021120

Bio Compression Systems, Inc

Multi-chamber venous compression system garment, reusable
Primary Device ID00812311021120
NIH Device Record Key31d34a3e-8e74-4322-a419-80104d876f7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio Compression Systems 4 Chamber Adjustable Extra Wide Leg
Version Model NumberGXWA-3045
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

Customer Support Contacts

Phone+1(201)340-6422
Emailbarbaraw@biocompression.com
Phone+1(201)340-6422
Emailbarbaraw@biocompression.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812311021120 [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 Number5
Public Version Date2020-01-29
Device Publish Date2017-11-21

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

00812311021120GXWA-3045
00812311022288GXWA-3045-BT

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