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 10885403532948 BD Alaris™ PCU Module, Model 8015 CAREFUSION 303, INC. FRN 2026-10-22 00856038001942 Iradimed IRADIMED CORP. FRN 2026-10-08 10885403519437 BD Alaris™ PCU Module, Model 8015 CAREFUSION 303, INC. FRN 2026-10-08 10885403533211 BD Alaris™ PCU Model 8015 CAREFUSION 303, INC. FRN 2026-10-08 10885403533273 BD Alaris™ Syringe Module Model 8110 CAREFUSION 303, INC. FRN 2026-10-08 10885403533297 BD Alaris™ PCU Model 8015 CAREFUSION 303, INC. FRN 2026-10-08 10885403533334 BD Alaris™ Syringe Module Model 8110 CAREFUSION 303, INC. FRN 2026-10-08 10885403533426 BD Alaris™ Pump Module, Model 8100 CAREFUSION 303, INC. FRN 2026-10-08 10885403535215 BD Alaris™ Pump Module, Model 8100 CAREFUSION 303, INC. FRN 2026-10-08 10885403542930 BD Alaris™ Pump Module, Model 8100 CAREFUSION 303, INC. FRN 2026-10-08 05060844770014 SAFIRA MEDOVATE LIMITED FRN 2026-10-05 05060844770021 SAFIRA MEDOVATE LIMITED FRN 2026-10-05 05060844770038 SAFIRA MEDOVATE LIMITED FRN 2026-10-05 05060844770045 SAFIRA MEDOVATE LIMITED FRN 2026-10-05 05060844770052 SAFIRA MEDOVATE LIMITED FRN 2026-10-05 04046955664214 B.BRAUN B. BRAUN MEDICAL INC. FRN 2026-07-12 04046961034704 Perfusor® B. BRAUN MEDICAL INC. FRN 2026-06-25 04046961034834 Perfusor® B. BRAUN MEDICAL INC. FRN 2026-06-25 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 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 30815112020034 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
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