Home GUDID 10355513770016 Repatha Pushtronex System
Primary DI 10355513770016
Brand Repatha Pushtronex System
Company AMGEN INC.
Model 9002870
Device description On-Body Infusor and Prefilled Cartridge
Published 2019-09-24
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FRN Pump, Infusion
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FRN Pump, Infusion General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10355513770016 Package GS1 20 In Commercial Distribution 00355513770019 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 10355513770016 10355513770016 00355513770019 00355513770019 355513770019 0355513770019
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 Total Volume 3.5 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 15 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Special Storage Condition, Specify 0 0 Do Not Freeze or Shake Special Storage Condition, Specify 0 0 Keep Dry Special Storage Condition, Specify 0 0 Keep out of the sight and reach of children Special Storage Condition, Specify 0 0 Store in Carton to Protect from Light Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 039976196 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product true Lot or batch true Serial number true Manufacturing date on label false Expiration date on label true 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 08500835120017 Avoset Optum Homecare Infusion Optum Distribution Center, LLC FRN 2026-02-24 17290109155309 Sapphire M.T. Pump Kit C EITAN MEDICAL LTD FRN 2024-09-04 30815112021345 Elution Test Vial Bracco Diagnostics Inc. FRN 2024-02-13 10815112021396 CardioGen-82 Infusion System Model 1700 Bracco Diagnostics Inc. FRN 2023-12-01 10815112021358 CardioGen Patient Administration Set Bracco Diagnostics Inc. FRN 2023-10-16 17290109155149 Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTD FRN 2023-09-05 30815112021338 Accessory Package Bracco Diagnostics Inc. FRN 2023-06-29 30815112020034 Accessory Package Bracco Diagnostics Inc. FRN 2023-03-22 30815112020614 Accessory Package Bracco Diagnostics Inc. FRN 2023-03-22 17290109154272 Sapphire Epidural Infusion Pump Kit – US EITAN MEDICAL LTD FRN 2022-05-15 17290109154289 Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTD FRN 2022-05-15 17290109154265 Sapphire M.T Infusion Pump Kit – US EITAN MEDICAL LTD FRN 2022-05-11 10814844000365 Curlin IV Pump System ZEVEX INTERNATIONAL, INC. FRN 2021-04-29 15019517177367 PharmGuard ICU MEDICAL, INC. FRN 2020-03-20 15019517177374 PharmGuard ICU MEDICAL, INC. FRN 2020-03-20 10884521064843 Kangaroo Cardinal Health, Inc. FRN 2019-12-30 15019517155143 MEDFUSION ICU MEDICAL, INC. FRN 2019-09-20 15019517155150 MEDFUSION ICU MEDICAL, INC. FRN 2019-09-20 15019517155167 MEDFUSION ICU MEDICAL, INC. FRN 2019-09-20 15019517178067 Medfusion ICU MEDICAL, INC. FRN 2019-09-18 20763000273334 MiniMed™ Reservoir MEDTRONIC MINIMED, INC. FRN 2019-09-02 20763000273358 MiniMed™ Reservoir MEDTRONIC MINIMED, INC. FRN 2019-09-02 M33513852011 Plum 360 ICU MEDICAL, INC. FRN 2019-02-15 70643169771481 MiniMed™ Reservoir MEDTRONIC MINIMED, INC. FRN 2018-05-31 08050616611635 APO-GO Syringe reservoir CANE' SPA FRN 2018-05-28 17290109150229 SapphirePlus Infusion Kit - US EITAN MEDICAL LTD FRN 2018-02-22 09350902001614 Flow Control Tubing GO MEDICAL INDUSTRIES PTY. LTD. FRN 2017-05-18 09350902001690 Flow Control Tubing GO MEDICAL INDUSTRIES PTY. LTD. FRN 2017-05-18 09350902001720 Flow Control Tubing GO MEDICAL INDUSTRIES PTY. LTD. FRN 2017-05-18 09350902001751 Flow Control Tubing GO MEDICAL INDUSTRIES PTY. LTD. FRN 2017-05-18