Bio Compression Systems Elite 8 Bio Vest Bilateral Arms

GUDID 00812311023018

Bio Compression Systems, Inc

Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable

• Primary Device ID: 00812311023018
• NIH Device Record Key: 15c62ca3-3e36-41e6-b97d-24089bc44b19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio Compression Systems Elite 8 Bio Vest Bilateral Arms
• Version Model Number: GV-3010-C-2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812311023018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142640

FDA Product Code

• 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: 2018-10-06

On-Brand Devices [Bio Compression Systems Elite 8 Bio Vest Bilateral Arms]

• 00812311023032: GV-3010-S-2
• 00812311023025: GV-3010-L-2
• 00812311023018: GV-3010-C-2