Home GUDID 05060116921328 Varithena® Administration Pack
Primary DI 05060116921328
Brand Varithena® Administration Pack
Company BIOCOMPATIBLES UK LTD
Model FP00024
Device description The Varithena® administration pack (convenience kit) contents: (1 Varithena Transfer Unit, 3 Silicon-free Syringes, 1 Manometer Tube and 2 Compression pads) . The administration pack is not subject to a 510K as each of the components has clearance as a medical device via a 510K (Syringe and Manometer Tubing) or 510K exempt devices (Compression Pads, Varithena Transfer Unit). The Varithena® administration pack is provided with the Varithena® drug product pack to the customer.
Published 2020-09-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05060116921328 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05060116921328 05060116921328 5060116921328
GMDN Terms# Term, Definition table Term Definition Medication transfer set A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.
Regulatory Flags# DUNS number 222870839 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05060116921168 LC Bead LUMI 100 - 300 RO2L103 2016-08-11 05060116921205 LC Bead LUMI 300 - 500 RO2L305 2016-08-11 05060116920635 TheraSphere Administration Set OTT-SPE-FP-001 2018-11-01 05060116921373 TheraSphere Y90 Glass Microspheres 3.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921380 TheraSphere Y90 Glass Microspheres 3.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921397 TheraSphere Y90 Glass Microspheres 4.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921403 TheraSphere Y90 Glass Microspheres 4.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921410 TheraSphere Y90 Glass Microspheres 5.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921427 TheraSphere Y90 Glass Microspheres 5.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921434 TheraSphere Y90 Glass Microspheres 6.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921441 TheraSphere Y90 Glass Microspheres 6.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921458 TheraSphere Y90 Glass Microspheres 7.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921465 TheraSphere Y90 Glass Microspheres 7.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921472 TheraSphere Y90 Glass Microspheres 8.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921489 TheraSphere Y90 Glass Microspheres 8.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921496 TheraSphere Y90 Glass Microspheres 9.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921502 TheraSphere Y90 Glass Microspheres 9.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921519 TheraSphere Y90 Glass Microspheres 10.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921526 TheraSphere Y90 Glass Microspheres 10.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921533 TheraSphere Y90 Glass Microspheres 11.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19
btgplc.com