8-Chamber Arm & Shoulder Sleeve - Small, Left

GUDID 00812311029096

Bio Compression Systems, Inc

Multi-chamber venous compression system garment, reusable
Primary Device ID00812311029096
NIH Device Record Keyb7aaa09b-ece1-4e97-922f-1038f1a98064
Commercial Distribution StatusIn Commercial Distribution
Brand Name8-Chamber Arm & Shoulder Sleeve - Small, Left
Version Model NumberG8-3035-SH-S-L
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
GS100812311029096 [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 Date2020-02-18
Device Publish Date2020-02-10

Devices Manufactured by Bio Compression Systems, Inc

00812311026255 - BioCryo Sequential Circulator2022-04-21
00812311020062 - 8-Chamber Arm & Shoulder Sleeve - Medium, Left2021-09-09 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
00812311020208 - 8-Chamber Arm & Shoulder Sleeve - Medium, Right2021-09-09
00812311021700 - Bio Compression Systems 8 Chamber Leg Sleeve - Large2021-09-09
00812311021717 - Bio Compression Systems 8 Chamber Leg Sleeve - Medium2021-09-09
00812311021724 - Bio Compression Systems 8 Chamber Leg Sleeve - Small2021-09-09
00812311021731 - Bio Compression Systems 4 Chamber Leg Sleeve Large Narrow2021-09-09
00812311021816 - Bio Compression Systems 4 Chamber Leg Sleeve Medium Narrow2021-09-09

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