NovoFine® 30G

Basic Information

• Brand Name: NovoFine® 30G
• Primary DI: 00301691852504
• Version / Model: 185250
• Catalog Number: 185250
• Company Name: NOVO NORDISK INC.
• Labeler DUNS: 012177531
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 3
• Public Version Date: 2022-11-18
• Public Version Status: Update
• Public Device Record Key: 4132104a-d8a8-4510-9c7b-a792b6310c32
• Distribution End Date: 2022-09-30

Device Description

NovoFine® 30G is a sterile, nontoxic, non-pyrogenic, single use injection needle designed and recommended for use with FlexPen® and all other Novo Nordisk® insulin delivery devices.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44127	Autoinjector needle	A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30301691852505	GS1		60	Not in Commercial Distribution	2022-09-30
Primary	00301691852504	GS1
Unit of Use	05712249050016	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	8	Millimeter
Needle Gauge	30	Gauge