Manifold

Basic Information

• Brand Name: Manifold
• Primary DI: 06971162812098
• Version / Model: M-03
• Catalog Number: 121003
• Company Name: Tianck Medical Co., Ltd.
• Labeler DUNS: 418642903
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-06
• Public Version: 2
• Public Version Date: 2023-05-18
• Public Version Status: Update
• Public Device Record Key: 5c2ed873-f9b9-4423-8491-0081073f757e

Device Description

Right off 500PSI

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
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	870.4290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63673	Infusion line manifold	A sterile, noninvasive device intended to provide multiple connections to an infusion fluid path. It consists of a straight-through infusion path with appropriate connectors at each end having multiple stopcock-controlled alternative connections to allow the injection/infusion of multiple different fluids/drugs. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971162812098	GS1
Package	16971162812095	GS1	middle pacage	25	In Commercial Distribution
Package	26971162812092	GS1	outer package	4	In Commercial Distribution