Home GUDID 20858835007985 Biotronix Healthcare Insulin Pen Needles
Primary DI 20858835007985
Brand Biotronix Healthcare Insulin Pen Needles
Company BIOTRONIX HEALTHCARE INDUSTRIES, INC.
Model GE44004
Device description Insulin Pen Needle 31G x 3/16"(5mm), Each
Published 2019-09-29
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 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 10858835007988 Package GS1 100 In Commercial Distribution 20858835007985 Package GS1 8 In Commercial Distribution 00858835007981 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 10858835007988 10858835007988 20858835007985 20858835007985 00858835007981 00858835007981 858835007981 0858835007981
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.
Regulatory Flags# DUNS number 065762392 Device count 1 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 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 05391530754439 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01 05391530754750 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01 05391530754798 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01 05391530755351 polycarbonate syringes DMC MEDICAL LIMITED FMF 2026-10-01 M99208012905P120LCH3 Livaclean Health Carelife (usa) Inc. FMF 2026-09-30 05391530754033 Polycarbonate Syringe DMC MEDICAL LIMITED FMF 2026-09-27 05391530754057 Polycarbonate Syringe DMC MEDICAL LIMITED FMF 2026-09-27
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