Sunmed Manifold and Stopcocks

Basic Information

• Brand Name: Sunmed Manifold and Stopcocks
• Primary DI: 06947358551904
• Version / Model: 500psi, off hand
• Company Name: Sunny Medical Device (Shenzhen) Co., Ltd.
• Labeler DUNS: 529639795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-15
• Public Version: 2
• Public Version Date: 2021-06-01
• Public Version Status: Update
• Public Device Record Key: a02a2c80-8866-4f3a-aa55-e52cc3c0b25f

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: 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
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	06947358551904	GS1