Jac-cell USA In.c

Basic Information

• Brand Name: Jac-cell USA In.c
• Primary DI: B461JAU11591
• Version / Model: JAU-1159
• Company Name: JAC CELL USA INC
• Labeler DUNS: 015023538
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-02-27
• Public Version: 3
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: d9cc7d3a-51a0-4614-93ae-6fcd24c41310

Device Description

Aspiration Tubing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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	B461JAU11591	HIBCC
Unit of Use	B461JAU115909	HIBCC