Bio Compression Systems Sequential Circulator Model SC-2004-C

GUDID 00812311021236

Bio Compression Systems, Inc

Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump

• Primary Device ID: 00812311021236
• NIH Device Record Key: 99e29925-5e29-447c-ab1e-a33d7bbffe42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio Compression Systems Sequential Circulator Model SC-2004-C
• Version Model Number: SC-2004-C
• 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: 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
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• Phone: +1(201)340-6422
• Email: barbaraw@biocompression.com
• 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	00812311021236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122112
• Premarket Notification: K961425

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: 2018-07-06
• 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