CircuCool™ 8005 Pump

GUDID 08714729454816

Model 8005 Pump

BOSTON SCIENTIFIC CORPORATION

Basic roller pump

• Primary Device ID: 08714729454816
• NIH Device Record Key: e9ccaf85-4772-471f-af46-fed22b6a6acf
• Commercial Distribution Discontinuation: 2020-12-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CircuCool™ 8005 Pump
• Version Model Number: M0048005R0
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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	08714729454816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980003

FDA Product Code

• LPB: Cardiac ablation percutaneous catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-11
• Device Publish Date: 2016-08-08

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729011378 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729011392 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729012580 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729012603 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729012610 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729056645 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729057062 - Lubriglide: 2024-12-23 Coated Guidewire
• 08714729080602 - MaxForce TTS: 2024-12-23 High Performance Balloon Dilatation Catheter