Bigger Better-Bladder BBB38

GUDID 00851997007011

CIRCULATORY TECHNOLOGY INC

Cardiotomy reservoir

• Primary Device ID: 00851997007011
• NIH Device Record Key: 7a4b0063-2d69-4458-9d7e-04c4d2d00bfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bigger Better-Bladder
• Version Model Number: BBB38
• Catalog Number: BBB38
• Company DUNS: 786778944
• Company Name: CIRCULATORY TECHNOLOGY 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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(516)624-2424
• Email: ytamari@cirtec.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851997007011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981284

FDA Product Code

• DTN: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Sterilization

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

[00851997007011]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-22
• Device Publish Date: 2016-10-03

Devices Manufactured by CIRCULATORY TECHNOLOGY INC

• 00851997007004 - Better-Bladder: 2020-01-22
• 00851997007011 - Bigger Better-Bladder: 2020-01-22
• 00851997007011 - Bigger Better-Bladder: 2020-01-22