NovoFine® Plus 32G

Basic Information

• Brand Name: NovoFine® Plus 32G
• Primary DI: 00301691856519
• Version / Model: 185651
• Catalog Number: 185651
• Company Name: NOVO NORDISK INC.
• Labeler DUNS: 012177531
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2017-12-06
• Public Version: 4
• Public Version Date: 2021-07-20
• Public Version Status: Update
• Public Device Record Key: 328afccf-58f2-40b3-ba20-518a0b1fcb80
• Distribution End Date: 2017-12-06

Device Description

NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.

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: 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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

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	30301691856510	GS1		288	Not in Commercial Distribution	2017-12-06
Primary	00301691856519	GS1
Unit of Use	05712249050122	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K133738	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	32	Gauge
Length	4	Millimeter