FDA.reportPublic FDA data

Varithena® Administration Pack

Primary DI
05060116921175
Brand
Varithena® Administration Pack
Company
BIOCOMPATIBLES UK LTD
Model
Version 1
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
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060116921175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060116921175050601169211755060116921175

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer setA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855 971 8346medical.services@btgplc.com

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 DIBrandModelCatalogPublished
05060116921168LC Bead LUMI 100 - 300RO2L1032016-08-11
05060116921205LC Bead LUMI 300 - 500RO2L3052016-08-11
05060116920635TheraSphere Administration SetOTT-SPE-FP-0012018-11-01
05060116921328Varithena® Administration PackFP000242020-09-30
05060116921373TheraSphere Y90 Glass Microspheres 3.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921380TheraSphere Y90 Glass Microspheres 3.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921397TheraSphere Y90 Glass Microspheres 4.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921403TheraSphere Y90 Glass Microspheres 4.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921410TheraSphere Y90 Glass Microspheres 5.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921427TheraSphere Y90 Glass Microspheres 5.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921434TheraSphere Y90 Glass Microspheres 6.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921441TheraSphere Y90 Glass Microspheres 6.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921458TheraSphere Y90 Glass Microspheres 7.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921465TheraSphere Y90 Glass Microspheres 7.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921472TheraSphere Y90 Glass Microspheres 8.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921489TheraSphere Y90 Glass Microspheres 8.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921496TheraSphere Y90 Glass Microspheres 9.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921502TheraSphere Y90 Glass Microspheres 9.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921519TheraSphere Y90 Glass Microspheres 10.0 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921526TheraSphere Y90 Glass Microspheres 10.5 GBq (US Commercial)OTT-SPE-FP-700 (990700.SPE)2020-06-19