Bio Compression Systems 4 Chamber Cryo Leg Extra Large - Black

GUDID 00812311021861

Bio Compression Systems, Inc

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 00812311021861
• NIH Device Record Key: 81092e01-42d8-4ff2-8d8c-25f930022540
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio Compression Systems 4 Chamber Cryo Leg Extra Large - Black
• Version Model Number: GC-3045-XL/B
• Company DUNS: 101393924
• Company Name: Bio Compression Systems, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812311021861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961425

FDA Product Code

• IRP: Massager, Powered Inflatable Tube
• JOW: SLEEVE, LIMB, COMPRESSIBLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-29
• Device Publish Date: 2017-11-21

Devices Manufactured by Bio Compression Systems, Inc

• 00812311026255 - BioCryo Sequential Circulator: 2022-04-21
• 00812311020062 - 8-Chamber Arm & Shoulder Sleeve - Medium, Left: 2021-09-09 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
• 00812311020208 - 8-Chamber Arm & Shoulder Sleeve - Medium, Right: 2021-09-09
• 00812311021700 - Bio Compression Systems 8 Chamber Leg Sleeve - Large: 2021-09-09
• 00812311021717 - Bio Compression Systems 8 Chamber Leg Sleeve - Medium: 2021-09-09
• 00812311021724 - Bio Compression Systems 8 Chamber Leg Sleeve - Small: 2021-09-09
• 00812311021731 - Bio Compression Systems 4 Chamber Leg Sleeve Large Narrow: 2021-09-09
• 00812311021816 - Bio Compression Systems 4 Chamber Leg Sleeve Medium Narrow: 2021-09-09