Home GUDID 05713495001043 VYAFUSER™
Primary DI 05713495001043
Brand VYAFUSER™
Company Phillips-Medisize A/S
Model VYAFUSER PUMP KIT US/PR A
Catalog number 2089870410
Device description The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV
Published 2024-11-13
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 05713495001043 Direct Marking GS1 0 05713495000169 Package GS1 4 In Commercial Distribution 05713495000152 Primary GS1 0 05713495001128 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05713495001043 05713495001043 5713495001043 05713495000169 05713495000169 5713495000169 05713495000152 05713495000152 5713495000152 05713495001128 05713495001128 5713495001128
GMDN Terms# Term, Definition table Term Definition Ambulatory syringe pump A battery-powered ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency; it is not dedicated to insulin infusion. Sometimes referred to as a portable syringe driver, it consists of a small unit with a syringe driving mechanism. It is used with a suitable injection/infusion set for delivery of small/finite volumes via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt or carried in a pocket and may be worn by the patient within and outside healthcare settings.
Device Sizes# Type, Value, Unit table Type Value Unit Depth 1.3 Inch Length 6.7 Inch Weight 285 Gram Width 3 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 15 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature 41 Degrees Fahrenheit 104 Degrees Fahrenheit Storage Environment Atmospheric Pressure 53.3 KiloPascal 106 KiloPascal Storage Environment Humidity 15 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -4 Degrees Fahrenheit 140 Degrees Fahrenheit
Regulatory Flags# DUNS number 306047440 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 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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