Home GUDID 10852282007157
Safe-T-Vue 6
Primary DI 10852282007157
Brand Safe-T-Vue 6
Company Temptime Corporation
Model STV6
Catalog number 7206-50
Device description A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Published 2019-10-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name KSS Supplies, Blood-Bank
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KSS Supplies, Blood-Bank Hematology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20852282007154 Package GS1 4 In Commercial Distribution 10852282007157 Primary GS1 0 00852282007150 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20852282007154 20852282007154 10852282007157 10852282007157 00852282007150 00852282007150 852282007150 0852282007150
GMDN Terms# Term, Definition table Term Definition Medical product temperature point indicator, thermochemical A small device intended to be attached to a bag containing a temperature-sensitive medical product (e.g., blood, pharmaceutical) to indicate, by non-reversible chemical colour change, when a predetermined temperature is reached and exceeded, potentially making the product non-viable. It typically consists of a self-adhesive plastic container that holds a patch of heat-sensitive material which is activated when the container is attached to the product of interest. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Refrigerate at the same temperature as the blood for a minimum of 24 hours prior to use. Storage Environment Temperature 1 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 152578522 Device count 50 Premarket exempt true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10852282007140 Safe-T-Vue 10 STV10 7201-50 2019-10-29 20852282007147 Safe-T-Vue 10 STV10 7201-50 2019-10-29 00852282007006 HEATmarker® Time-Temperature Indicators: F3 F3 2016-09-23 00852282007013 HEATmarker® Time-Temperature Indicators: F6 F6 2016-09-23 00852282007020 HEATmarker® Time-Temperature Indicators: F9 F9 2016-09-23 00852282007037 HEATmarker® Time-Temperature Indicators: F12 F12 2016-09-23 00852282007044 HEATmarker® Time-Temperature Indicators: F24 F24 2016-09-23 00852282007051 HEATmarker® Time-Temperature Indicators: F36 F36 2016-09-23 00852282007068 HEATmarker® Time-Temperature Indicators: CT2 CT2 2016-09-23 00852282007075 HEATmarker® Time-Temperature Indicators: CT3 CT3 2016-09-23 00852282007082 HEATmarker® Time-Temperature Indicators: CT4 CT4 2016-09-23 00852282007099 HEATmarker® Time-Temperature Indicators: CT6 CT6 2016-09-23 00852282007105 HEATmarker® Time-Temperature Indicators: CT9 CT9 2016-09-23 00852282007112 HEATmarker® Time-Temperature Indicators: CT24 CT24 2016-09-23 00852282007129 HEATmarker® Time-Temperature Indicators: CT12 CT12 2016-09-23 00852282007136 HEATmarker® Time-Temperature Indicators: CT36 CT36 2016-09-23
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