ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 00801902003652
• Version / Model: IPN035959
• Catalog Number: UH-14703
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 5
• Public Version Date: 2019-01-07
• Public Version Status: Update
• Public Device Record Key: db7fb05e-fa9b-4ae9-9c14-73fdf4b828b0

Device Description

UserGard(R) Needle-Free Injection Hub

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
LJS	Catheter,intravascular,therapeutic,long-term greater than 30 days	General Hospital	880.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42631	Split-septum needleless valve-connector	A small, sterile, stand-alone, needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position, and through which IV access is gained via blunt cannula separation of a septum. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30801902003653	GS1	Case	2	In Commercial Distribution
Package	20801902003656	GS1	Box	50	In Commercial Distribution
Primary	00801902003652	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K923653	000