8-Chamber Arm & Shoulder Sleeve - Medium, Left

GUDID 00812311020062

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

Bio Compression Systems, Inc

Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable
Primary Device ID00812311020062
NIH Device Record Key10465494-dbec-4f04-9b0d-73cc2ba4d036
Commercial Distribution StatusIn Commercial Distribution
Brand Name8-Chamber Arm & Shoulder Sleeve - Medium, Left
Version Model NumberG8-3035-SH-M-L-BT
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
GS100812311020062 [Primary]

FDA Product Code

JOWSLEEVE, LIMB, COMPRESSIBLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-09
Device Publish Date2021-09-01

On-Brand Devices [8-Chamber Arm & Shoulder Sleeve - Medium, Left]

00812311029119G8-3035-SH-M-L
00812311020062https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#

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