Multi-FLO DVT Combo Cyro Ankle Sleeve

GUDID 00812311020543

Bio Compression Systems, Inc

Hot/cold therapy pack, reusable
Primary Device ID00812311020543
NIH Device Record Key2fe862e1-5248-4e52-9601-aef636a9dde5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-FLO DVT Combo Cyro Ankle Sleeve
Version Model NumberGC1-3045-A
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812311020543 [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 Number2
Public Version Date2020-01-29
Device Publish Date2019-04-09

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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