BioTab Sequential Circulator

GUDID 00812311024480

Bio Compression Systems, Inc

Sequential venous compression system pump

• Primary Device ID: 00812311024480
• NIH Device Record Key: 715bd4b7-ed66-4169-a8f8-22d0ba3ed06a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioTab Sequential Circulator
• Version Model Number: SC-4008-DL-BT
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	00812311024480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210417

FDA Product Code

• JOW: SLEEVE, LIMB, COMPRESSIBLE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-08
• Device Publish Date: 2021-08-31

On-Brand Devices [BioTab Sequential Circulator]

• 00812311029027: SC-3008-DL-BT
• 00812311029010: SC-2004-OC-BT
• 00812311024480: SC-4008-DL-BT
• 00812311024244: SC-2004-DL-BT