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 05391530753944 FD-1017NS - 1ml PC Syringe - White Plunger DMC MEDICAL LIMITED FMF 2026-06-03 05391530753951 FD-1018NS - 1ml PC Syringe - Blue Plunger DMC MEDICAL LIMITED FMF 2026-06-03 05391530754217 FD-1078NS 20ml PC Syringe - White Plunger - Saline Print DMC MEDICAL LIMITED FMF 2026-06-03 05391530754620 FD-1048NS 10ml PC Syringe Yellow Plunger Lidocaine DMC MEDICAL LIMITED FMF 2026-06-03 05391530754699 FD-1075NS 10ml PC Syringe Light Blue Plunger Xylocaine DMC MEDICAL LIMITED FMF 2026-06-03 05391530754941 FD-1180NS 3ml Nugen Syringe Red Plunge DMC MEDICAL LIMITED FMF 2026-06-03 05391530754965 FD-1162NS 10ml Nugen Syringe Red Plunger DMC MEDICAL LIMITED FMF 2026-06-03 05391530753968 FD-1019NS - 1ml PC Syringe - Yellow Plunger DMC MEDICAL LIMITED FMF 2026-06-02 05391530754088 FD-1021NS 3ml PC Syringe White Plunger DMC MEDICAL LIMITED FMF 2026-06-02 05391530754194 FD-1034NS 20ml PC Syringe Red Plunger DMC MEDICAL LIMITED FMF 2026-06-02 05391530754224 FD-1033NS 20ml PC Syringe - Yellow Plunger DMC MEDICAL LIMITED FMF 2026-06-02 05391530754231 FD-1092NS 20ml PC Syringe Heparin Print - Red Plunger DMC MEDICAL LIMITED FMF 2026-06-02 05391530753456 FD-1032NS - 20ml PC Syringe Blue Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753463 FD-1031NS - 20ml PC Syringe White Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753487 FD-1113NS - 10ml PC Syringe Contrast Dark Green Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753517 FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine Print DMC MEDICAL LIMITED FMF 2026-06-01 05391530753524 FD-1043NS - 10ml PC Syringe - Contrast - Yellow Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753531 FD-1107NS - 30ml PC Syringe - Yellow Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753548 FD-1026NS - 10ml PC Syringe - White Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753555 FD-1158NS - 10ml PC Syringe - Heparin/Saline White Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753562 FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753579 FD-1029NS - 10ml PC Syringe Red Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753593 FD-1054NS - 10ml PC Syringe - Nitro Print - Red Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753609 FD-1039NS - 10ml PC Syringe - Heparin Print - Red Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753616 FD-1071NS - 10ml PC Syringe - Purple Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753623 FD-1028NS - 10ml PC Syringe - Yellow Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753647 FD-1072NS - 10ml PC Syringe Dark Green Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753654 FD-1030NS - 10ml PC Syringe - Light Green Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753661 FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue Plunger DMC MEDICAL LIMITED FMF 2026-06-01 05391530753678 FD-1044NS - 10ml PC Syringe - Contrast Print - Red Plunger DMC MEDICAL LIMITED FMF 2026-06-01