Manifold Set

Basic Information

• Brand Name: Manifold Set
• Primary DI: 10816203020038
• Version / Model: 4S-4M60
• Company Name: ORIGEN BIOMEDICAL, INC.
• Labeler DUNS: 625272232
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c78e3024-2e23-4eca-b81b-58e4a297566f

Device Description

Four spikes to four male luers with 60cm SCD tubing, roller and pinch clamps

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: 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
KJG	Tube, Tissue Culture	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60540	Intravenous fluid bag spike	A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10816203020038	GS1
Package	20816203020035	GS1	Case	12	In Commercial Distribution

Customer Contacts

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