Home GUDID 00384703540033 Unifine Pentips - 4mm x 32G
Primary DI 00384703540033
Brand Unifine Pentips - 4mm x 32G
Company OWEN MUMFORD USA INCORPORATED
Model AN3540
Catalog number AN3540
Device description For use with injectors for the subcutaneous injection of approved drugs, including insulin
Published 2016-09-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
Sterile true
Single use true Product Codes# Code, Name table Code Name FMI Needle, Hypodermic, Single Lumen
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMI Needle, Hypodermic, Single Lumen General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00384703540026 Package GS1 10 In Commercial Distribution 00384703540033 Package GS1 50 In Commercial Distribution 00384703540019 Primary GS1 0 00384703540002 Unit of Use GS1 0 00384703540009 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 00384703540026 00384703540026 384703540026 0384703540026 00384703540033 00384703540033 384703540033 0384703540033 00384703540019 00384703540019 384703540019 0384703540019 00384703540002 00384703540002 384703540002 0384703540002 00384703540009 00384703540009 384703540009 0384703540009
GMDN Terms# Term, Definition table Term Definition Autoinjector needle A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 4 Millimeter Needle Gauge 32 Gauge
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 803401454 Device count 100 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810011730809 huahong Tianjin Huahong Technology Co., Ltd. FMI 2026-07-10 00810011730816 QikDiag Tianjin Huahong Technology Co., Ltd. FMI 2026-07-10 16972857297784 Easydrip Glider5 Classic Pro Pen Needles Sandstone Medical (Suzhou) Inc. FMI 2026-07-09 16972857297791 Easydrip PentaGlider Plus Pro Pen Needles Sandstone Medical (Suzhou) Inc. FMI 2026-07-09 20192253036982 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253036999 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037026 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037033 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037040 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037064 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037071 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037088 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037101 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037125 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037132 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037156 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037194 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037200 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037255 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037262 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253037279 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253038269 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253038283 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253038290 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253038313 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253038337 Monoject Cardinal Health 200, LLC FMI 2026-07-09 20192253038368 Monoject Cardinal Health 200, LLC FMI 2026-07-09 00857273002602 droplet® pen needles HTL STREFA S A FMI 2026-07-05 M6898250403050 MEDIC ENHANCEMENT SET Safeguard US Operating, LLC FMI 2026-06-03 08056999020279 SurTract™ RONCADELLE OPERATIONS SRL FMI 2026-05-31
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