EXEL Aluminum Hub Needles 18G X 3/4"

Basic Information

• Brand Name: EXEL Aluminum Hub Needles 18G X 3/4"
• Primary DI: 00020221264616
• Version / Model: 26461
• Catalog Number: 26461
• Company Name: Exel International
• Labeler DUNS: 180572216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-16
• Public Version: 1
• Public Version Date: 2023-03-24
• Public Version Status: New
• Public Device Record Key: 3fe9748f-1fff-41a7-9063-203b9d9f57fb

Device Description

EXEL Aluminum Hub Needles 18G X 3/4"; 100/BX, 1000/CS, 4CS/CRTN

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: 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
59230	Hypodermic needle, single-use	A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10020221264613	GS1	Inner box	100	In Commercial Distribution
Primary	00020221264616	GS1
Package	20020221264610	GS1	Outer box	10	In Commercial Distribution
Package	30020221264617	GS1	Shipping carton	4	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K101309	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius