Home GUDID 00198815000152 Takeda Convenience Kit
Primary DI 00198815000152
Brand Takeda Convenience Kit
Company Takeda Pharmaceuticals U.S.A., Inc.
Model 6525066
Catalog number 6525066
Device description Convenience Kit containing one 13 mm vial adapter and one 27Gx1/2 inch needle for subcutaneous administration of a reconstituted drug product
Published 2026-07-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name POR Parenteral Administration Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class POR Parenteral Administration Kit General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00198815000152 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 00198815000152 00198815000152 198815000152 0198815000152
GMDN Terms# Term, Definition table Term Definition General-purpose hypodermic injection kit A collection of devices which includes a hypodermic needle(s) intended to be used by a healthcare practitioner for administration of fluids (e.g., medication) into a patient; it is not dedicated to a specific clinical specialty and is not intended for self-administration. In addition to the hypodermic needle, it includes a syringe (which may have a Luer-lock adaptor for use during intravenous (IV) administration via connection to an IV line) and additional supportive devices [e.g., adhesive strip/plaster, alcohol wipes, antiseptic agents, disposable gloves]. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Controlled Room Temperature 20°C – 25°C
Regulatory Flags# DUNS number 041877817 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true 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 false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850025688888 Anti-Drug Antibody Biomarker Specimen Collection Kit 5000833 5000833 2023-10-30 00850025688963 HyHub Duo Vial Access Device 6520083 6520083 2025-09-23 00850025688291 HyHub Vial Access Device 5500222 5500222 2025-09-23 00198815000107 Recombinant Factor VIII Substrate, Porcine Sequence 6521753 6521753 2025-08-01 00850025688819 myPKFiT for Healthcare Professionals V3 2025-01-03 00850025688826 myPKFiT for Patients Mobile Application V2 2025-01-03 00850025688871 BAXJECT II Hi-Flow 3400769 2024-06-12 00850025688864 BAXJECT II 6507816 6507816 2024-02-29
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04046955251704 Subcutaneous Injection Supply Kit 2 B. Braun Melsungen Aktiengesellschaft POR 2018-09-03 04046955251711 Subcutaneous Injection Supply Kit 2 B. Braun Melsungen Aktiengesellschaft POR 2018-09-03 04046955096756 Subcutaneous Injection Supply Kit B. Braun Melsungen Aktiengesellschaft POR 2017-08-07 04046955096763 Subcutaneous Injection Supply Kit B. Braun Melsungen Aktiengesellschaft POR 2017-08-07