HEATmarker® Time-Temperature Indicators: F12

GUDID 00852282007037

Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 5°C.

Temptime Corporation

Medical product temperature point indicator, thermochemical
Primary Device ID00852282007037
NIH Device Record Key37e938d6-a618-4e5b-8fd7-9d7515255f76
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEATmarker® Time-Temperature Indicators: F12
Version Model NumberF12
Company DUNS152578522
Company NameTemptime Corporation
Device Count1
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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 0 Degrees Celsius and -24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100852282007037 [Primary]

FDA Product Code

JOJIndicator, Physical/Chemical Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-21
Device Publish Date2016-09-23

Devices Manufactured by Temptime Corporation

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: F122019-02-21Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 5°C.
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

Trademark Results [HEATmarker]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEATMARKER
HEATMARKER
86503527 4799295 Live/Registered
Temptime Corporation
2015-01-14
HEATMARKER
HEATMARKER
86503481 4799293 Live/Registered
Temptime Corporation
2015-01-14
HEATMARKER
HEATMARKER
78721582 3173645 Live/Registered
Temptime Corporation
2005-09-27
HEATMARKER
HEATMARKER
75090076 2064872 Live/Registered
TEMPTIME CORPORATION
1996-03-08

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