R Med Collection Set

Basic Information

• Brand Name: R Med Collection Set
• Primary DI: B49746721COLLSE0
• Version / Model: CollSe
• Company Name: R MEDICAL SUPPLY INC
• Labeler DUNS: 788124873
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-18
• Public Version: 3
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 65f00c8a-52b6-4901-b45d-fae51b8bb0f3

Device Description

Vacuum Tubing with handle and adapter; single use, sterile, flexible, 6' long, 1/2" outer diameter.

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46721	Disposable vacuum tubing	A sterile length of flexible tube intended to be used as a connection line between a vacuum source and a medical device, medical equipment, or a medical system that is dependent upon suction to operate or function. It is typically made of malleable synthetic polymer material(s) (e.g., plastic, silicone) and is designed with a thick wall to prevent collapse due to the negative pressure of the vacuum; it is available in a variety of lengths, including standard coil lengths. This device is used when sterile conditions are required (e.g., for an autologous blood transfusion system). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B49746721COLLSE0	HIBCC

Customer Contacts

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