Home GUDID 30815112021390 CardioGen-82 Infusion System Model 1700
Primary DI 30815112021390
Brand CardioGen-82 Infusion System Model 1700
Company BRACCO DIAGNOSTICS INC
Model 001700
Device description Infusion system for Rubidium-82 saline injection.
Published 2023-12-01
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use false 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 30815112021390 Package GS1 1 In Commercial Distribution 10815112021396 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30815112021390 30815112021390 10815112021396 10815112021396
GMDN Terms# Term, Definition table Term Definition Bedside infusion pump, single-channel An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 30 Percent (%) Relative Humidity 60 Percent (%) Relative Humidity Handling Environment Temperature 20 Degrees Celsius 25 Degrees Celsius Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 849234661 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product true Lot or batch false Serial number true Manufacturing date on label true 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 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
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