TUBING BEND RELIEF

Basic Information

• Brand Name: TUBING BEND RELIEF
• Primary DI: 07640135140399
• Version / Model: 201-50126
• Catalog Number: 201-50126
• Company Name: Thoratec Switzerland GmbH
• Labeler DUNS: 486066918
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2014-09-20
• Public Version: 6
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: dadf48de-65d9-42f7-abff-0065b1d5a5f2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	870.4360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64085	Non-ISO80369-standardized small-bore linear connector, reusable	A small, non-powered, noninvasive, small-bore, tubular, two-way/linear connector with a connection at each end (typically barbed, bayonet, conical, threaded and/or non-Luer-slip) which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp, tubing nor puncturing component, and is not a dedicated gas-line connector. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640135140399	GS1
Unit of Use	07640135140382	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 79.3 – 101.3 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity