Home GUDID 10384571140028 ZIMHI
Primary DI 10384571140028
Brand ZIMHI
Company ZMI Pharma Inc
Model 1
Device description ZIMHI® (naloxone HCl Injection, USP) 5 mg/0.5 mL FOR INTERMUSCULAR OR SUBCUTANEOUS INJECTION
Published 2026-01-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use 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 10384571140028 Package GS1 12 In Commercial Distribution 20384571140025 Package GS1 280 In Commercial Distribution 00384571140021 Primary GS1 0 00384571140113 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10384571140028 10384571140028 20384571140025 20384571140025 00384571140021 00384571140021 384571140021 0384571140021 00384571140113 00384571140113 384571140113 0384571140113
GMDN Terms# Term, Definition table Term Definition Prefilled syringe/needle A device consisting of a calibrated barrel (cylinder) with plunger and an attached needle, which is prefilled with a pharmaceutical (e.g., insulin, anti-rheumatic drug), intended to be used by a patient or carer for subcutaneous or intramuscular manual injection of a single dose of the medication/pharmaceutical; it is not intended for anaesthesia/nerve block. Procedural supportive devices (e.g., dressings, antiseptic wipes) may be included with the syringe. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 68 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 119298269 Device count 2 DM exempt false Premarket exempt true HCT/P false Kit false Combination product true Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00384571140021 ZIMHI 1 2026-01-16
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10840330704868 ProCure Twin Med, LLC FMF 2026-05-27 10840330704875 ProCure Twin Med, LLC FMF 2026-05-27 08800052609303 "Sure Fine Insulin Syringe 0.3cc 31G x 1/4""" SHINA MED CORPORATION FMF 2026-03-25 08800052609310 "Sure Fine Insulin Syringe 0.3cc 31G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609327 "Sure Fine Insulin Syringe 0.3cc 30g x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609334 "Sure Fine Insulin Syringe 0.3cc 30G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609341 "Sure Fine Insulin Syringe 0.5cc 31G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609358 "Sure Fine Insulin Syringe 0.5cc 30G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609365 "Sure Fine Insulin Syringe 0.5cc 30G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609372 "Sure Fine Insulin Syringe 0.5cc 29G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609389 "Sure Fine Insulin Syringe 1.0cc 31G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609396 "Sure Fine Insulin Syringe 1.0cc 30g x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609402 "Sure Fine Insulin Syringe 1.0cc 30G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609419 "Sure Fine Insulin Syringe 1.0cc 29G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609426 "Sure Fine Insulin Syringe 0.3cc 31G x 1/4""" SHINA MED CORPORATION FMF 2026-03-25 08800052609433 "Sure Fine Insulin Syringe 0.3cc 31G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609440 "Sure Fine Insulin Syringe 0.3cc 30g x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609457 "Sure Fine Insulin Syringe 0.3cc 30G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609464 "Sure Fine Insulin Syringe 0.5cc 31G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609471 "Sure Fine Insulin Syringe 0.5cc 30G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609488 "Sure Fine Insulin Syringe 0.5cc 30G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609495 "Sure Fine Insulin Syringe 0.5cc 29G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609501 "Sure Fine Insulin Syringe 1.0cc 31G x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609518 "Sure Fine Insulin Syringe 1.0cc 30g x 5/16""" SHINA MED CORPORATION FMF 2026-03-25 08800052609525 "Sure Fine Insulin Syringe 1.0cc 30G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08800052609532 "Sure Fine Insulin Syringe 1.0cc 29G x 1/2""" SHINA MED CORPORATION FMF 2026-03-25 08699207302028 Set Inject SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI FMF 2026-03-17 08699207305036 Set Inject SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI FMF 2026-03-17 08699207310030 Set Inject SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI FMF 2026-03-17 08699207311006 Set Inject SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI FMF 2026-03-17