Home GUDID 30301691854592 NovoPen Echo®
Primary DI 30301691854592
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
OTC false
Sterile false
Single use false
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 Cartridge-accepting autoinjector, 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 to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and typically a dial on the device is operated for dosing (e.g., via a spring-loaded mechanism); the cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Room temperature
Regulatory Flags# DUNS number 012177531 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product true Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10816336022275 NC600300-ENF NEOCHILD, LLC FMF 2026-07-23 10816336022282 NC602000-ENF NEOCHILD, LLC FMF 2026-07-23 10816336022442 NC600100-ENF NEOCHILD, LLC FMF 2026-07-23 00884450492888 Merit Medical® Merit Medical Systems, Inc. FMF 2026-07-22 10383017593015 Ultra-Fine SAFETY Embecta Medical II, LLC FMF 2026-07-21 10383017593213 Ultra-Fine SAFETY Embecta Medical II, LLC FMF 2026-07-21 10383017593411 Ultra-Fine SAFETY Embecta Medical II, LLC FMF 2026-07-21 10383017593510 Ultra-Fine SAFETY Embecta Medical II, LLC FMF 2026-07-21 10383017593718 Ultra-Fine SAFETY Embecta Medical II, LLC FMF 2026-07-21 10383017844612 Ultra-Fine SAFETY Embecta Medical II, LLC FMF 2026-07-21 10383017844711 Ultra-Fine SAFETY Embecta Medical II, LLC FMF 2026-07-21 10383017844919 Ultra-Fine SAFETY Embecta Medical II, LLC FMF 2026-07-21 18257200121076 O-GENESIS Orthofix US LLC FMF 2026-07-17 18257200121083 O-GENESIS Orthofix US LLC FMF 2026-07-17 05391530753944 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-03 05391530753951 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-03 05391530754217 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-03 05391530754620 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-03 05391530754699 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-03 05391530754941 NuGen syringe DMC MEDICAL LIMITED FMF 2026-06-03 05391530754965 NuGen syringe DMC MEDICAL LIMITED FMF 2026-06-03 05391530753968 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-02 05391530754088 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-02 05391530754194 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-02 05391530754224 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-02 05391530754231 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-02 05391530753456 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-01 05391530753463 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-01 05391530753487 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-01 05391530753517 Polycarbonate syringe DMC MEDICAL LIMITED FMF 2026-06-01