Safe-T-Vue 10 7201-50

GUDID 20852282007147

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.

Temptime Corporation

Medical product temperature point indicator, thermochemical
Primary Device ID20852282007147
NIH Device Record Keyc955e39b-88e2-4eb0-9216-7c2092225291
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafe-T-Vue 10
Version Model NumberSTV10
Catalog Number7201-50
Company DUNS152578522
Company NameTemptime Corporation
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone973-630-6000
Emailinfo@temptimecorp.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100852282007143 [Unit of Use]
GS110852282007140 [Primary]
GS120852282007147 [Package]
Contains: 10852282007140
Package: Case of 200 [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSSSupplies, Blood-Bank

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-06
Device Publish Date2019-10-29

Devices Manufactured by Temptime Corporation

20852282007147 - Safe-T-Vue 102019-11-06A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
20852282007147 - Safe-T-Vue 102019-11-06 A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceede
10852282007157 - Safe-T-Vue 62019-11-06 A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceede
00852282007006 - HEATmarker® Time-Temperature Indicators: F32019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t
00852282007013 - HEATmarker® Time-Temperature Indicators: F62019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t
00852282007020 - HEATmarker® Time-Temperature Indicators: F92019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t
00852282007037 - HEATmarker® Time-Temperature Indicators: F122019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t
00852282007044 - HEATmarker® Time-Temperature Indicators: F242019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t
00852282007051 - HEATmarker® Time-Temperature Indicators: F362019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t

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