Home GUDID 00811505030573
Ivenix
Primary DI 00811505030573
Brand Ivenix
Company Fresenius Kabi AG
Model SET-0040-1
Catalog number SET-0040-1
Device description LVP Primary Administration Set
Published 2026-06-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name FPA Set, administration, intravascular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FPA Set, Administration, Intravascular General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10811505030570 Package GS1 25 In Commercial Distribution 00811505030573 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 10811505030570 10811505030570 00811505030573 00811505030573 811505030573 0811505030573
GMDN Terms# Term, Definition table Term Definition Electric infusion pump administration set, single-use A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 0 Special Storage Condition, Specify 0 0 Do not use if package is opened or damaged Special Storage Condition, Specify 0 0 Keep Dry Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 315654579 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00811137013104 Amicus Separator 6R4590R 6R4590R 2026-03-11 00810020442229 Amicus MNC Apheresis Kit - Double Needle X7R2326SB X7R2326SB 2026-02-03 01081002044222 Amicus MNC Apheresis Kit - Double Needle X7R2326SB X7R2326SB 2026-02-03 04086000860888 COMPOGUARD Advance Basic 9029741 9029741 2024-10-30 04086000860895 COMPOGUARD Advance Data 9029751 9029751 2024-10-29 04086000860901 COMPOGUARD Advance COMPLETE 9029761 9029761 2024-10-29 04086000860741 CompoGuard Basic (NA) 9029641 9029641 2022-11-10 04086000860758 CompoGuard Data (NA) 9029651 9029651 2022-11-10 04086000860765 CompoGuard Complete (NA) 9029661 9029661 2022-11-10 04086000100199 ALYX 2RBC LR KIT X4R5720 X4R5720 2018-02-14 04086000100991 Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed 4R2367 4R2367 2016-09-09 04086000100984 Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed 4R2365 4R2365 2016-09-09 00810020440164 AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly 4R2353G 4R2353G 2020-10-20 04086000101370 Fenwal AMICUS Single Needle Advanced Kit 4R2353 4R2353 2016-09-02 04086000101387 Fenwal AMICUS Double Needle Advanced Kit 4R2354 4R2354 2016-09-02 00810020440140 AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly 4R2354G 4R2354G 2020-10-20 04086000101332 Fenwal AMICUS Apheresis Kit - Double Needle 4R2355 4R2355 2016-09-09 04086000101349 Fenwal AMICUS Apheresis Kit - Single Needle 4R2357 4R2357 2016-09-09 04086000100090 AMICUS Apheresis Kit – Single Needle X6R2312 X6R2312 2025-11-03 00810020441062 Fenwal Hand Sealer 4R4454W 4R4454W 2025-04-30
Other Devices Sharing Product Codes#