Bio Compression Systems 8 Chamber Leg Sleeve - Medium Adjustable

GUDID 00812311020024

Bio Compression Systems, Inc

Multi-chamber venous compression system garment, reusable
Primary Device ID00812311020024
NIH Device Record Keyae821a27-bb78-4765-80b0-c245de5c787b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio Compression Systems 8 Chamber Leg Sleeve - Medium Adjustable
Version Model NumberA8-3045-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

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
GS100812311020024 [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 Date2019-12-06
Device Publish Date2017-11-21

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.