Home GUDID 00301691854591 NovoPen Echo®
Primary DI 00301691854591
Brand NovoPen Echo®
Company NOVO NORDISK INC.
Model 185459
Catalog number 185459
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.
Published 2016-11-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name FMF Syringe, Piston
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMF Syringe, Piston General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30301691854592 Package GS1 16 In Commercial Distribution 00301691854591 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 30301691854592 30301691854592 00301691854591 00301691854591 301691854591 0301691854591
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 012177531 Device count 1 Combination product true Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 09347144013062 Metier Medical METIER MEDICAL LTD FMF 2026-10-19 09347144013123 Metier Medical METIER MEDICAL LTD FMF 2026-10-19 09347144015004 Metier Medical METIER MEDICAL LTD FMF 2026-10-12 09347144016186 Metier Medical METIER MEDICAL LTD FMF 2026-10-12 09347144016216 Metier Medical METIER MEDICAL LTD FMF 2026-10-12 20612479288496 McKesson MCKESSON MEDICAL-SURGICAL INC. FMF 2026-10-08 20612479288526 McKesson MCKESSON MEDICAL-SURGICAL INC. FMF 2026-10-08 10304040193843 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193850 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193867 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193874 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193881 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040193898 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194109 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194116 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194208 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194215 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194222 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194239 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194246 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194253 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194260 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194277 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194284 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194291 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194307 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 10304040194314 Henry Schein HENRY SCHEIN, INC. FMF 2026-10-05 05391530753982 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01 05391530753999 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01 05391530754408 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01
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