EXEL HIS ROTATING WING, NON-DEHP W/Y 22GX1"

Basic Information

• Brand Name: EXEL HIS ROTATING WING, NON-DEHP W/Y 22GX1"
• Primary DI: 00020221079487
• Version / Model: 27948R
• Catalog Number: 27948R
• Company Name: Exel International
• Labeler DUNS: 180572216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-07
• Public Version: 1
• Public Version Date: 2023-04-17
• Public Version Status: New
• Public Device Record Key: 393d92f8-af7e-4b83-a99d-1c23f54a9fad

Device Description

EXEL HIS ROTATING WING, NON-DEHP W/Y 22GX1", 25/INNERBX, 50/BX, 20BX/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
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17180	Subcutaneous infusion/injection port needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10020221079484	GS1	Inner box	25	In Commercial Distribution
Primary	00020221079487	GS1
Package	20020221079481	GS1	Case	2	In Commercial Distribution
Package	30020221079488	GS1	Shipping carton	20	In Commercial Distribution

Storage Conditions

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