EXEL BLUNT TIP ALUMINUM STERILE HUB NEEDLE

Basic Information

• Brand Name: EXEL BLUNT TIP ALUMINUM STERILE HUB NEEDLE
• Primary DI: 00020221264746
• Version / Model: 26474
• Catalog Number: 26474
• Company Name: Exel International
• Labeler DUNS: 180572216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-16
• Public Version: 3
• Public Version Date: 2023-10-03
• Public Version Status: Update
• Public Device Record Key: 5a5aea6e-9391-4996-8fe7-9961eccadbc8

Device Description

Needle, 19G X 1 1/2"; 25 PCS/BOX, 100 PCS/CASE, 10CS/CRTN

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: 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
LHI	Set, I.V. Fluid Transfer	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43324	Fluid transfer set, general-purpose	A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30020221264747	GS1	Carton	10	In Commercial Distribution
Package	20020221264740	GS1	Case	4	In Commercial Distribution
Package	10020221264743	GS1	Box	25	In Commercial Distribution
Primary	00020221264746	GS1
Package	40020221264744	GS1	Export carton	4	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101309	000