NovoPen Echo®

Basic Information

• Brand Name: NovoPen Echo®
• Primary DI: 00301691854591
• Version / Model: 185459
• Catalog Number: 185459
• Company Name: NOVO NORDISK INC.
• Labeler DUNS: 012177531
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-23
• Public Version: 8
• Public Version Date: 2026-02-02
• Public Version Status: Update
• Public Device Record Key: c1f2ce55-8d94-40ca-bdea-a4e2bde80b5c

Device Description

NovoPen Echo® is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45771	Empty self-injector, mechanical	A portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient or carer for subcutaneous or intramuscular injection of a dose of the pharmaceutical agent via a replaceable needle. A dial on the injector is operated for dosing (e.g., via a spring-loaded mechanism). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30301691854592	GS1		16	In Commercial Distribution
Primary	00301691854591	GS1

Customer Contacts

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