TubingCRF

Basic Information

• Brand Name: TubingCRF
• Primary DI: 00811746030394
• Version / Model: CRF-TUBE
• Catalog Number: CRF-TUBE
• Company Name: CAMBRIDGE INTERVENTIONAL LLC
• Labeler DUNS: 080897872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-30
• Public Version: 2
• Public Version Date: 2023-09-27
• Public Version Status: Update
• Public Device Record Key: e8d95d0c-dd93-4d5b-ae8c-42aa91cd6d7e

Device Description

CRF Tubing Set

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37147	Cooling utility supply system	An assembly of devices designed to provide utilities/amenities (e.g., water, compressed air) to cool other medical devices, data equipment, or laboratory devices/equipment to facilitate their operation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10811746030391	GS1		2	In Commercial Distribution
Primary	00811746030394	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192715	000