HEATmarker® Time-Temperature Indicators: F9

GUDID 00852282007020

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 9 months at 5°C.

Temptime Corporation

Medical product temperature point indicator, thermochemical

• Primary Device ID: 00852282007020
• NIH Device Record Key: 1e3405a5-3f19-42e0-a416-51cb2b228be0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEATmarker® Time-Temperature Indicators: F9
• Version Model Number: F9
• Company DUNS: 152578522
• Company Name: Temptime Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 973-630-6000
• Email: info@temptimecorp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852282007020 [Primary]

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-23

Devices Manufactured by Temptime Corporation

• 20852282007147 - Safe-T-Vue 10: 2019-11-06 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 6: 2019-11-06 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: F3: 2019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t
• 00852282007013 - HEATmarker® Time-Temperature Indicators: F6: 2019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t
• 00852282007020 - HEATmarker® Time-Temperature Indicators: F9: 2019-02-21Time-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 9 months at 5°C.
• 00852282007020 - HEATmarker® Time-Temperature Indicators: F9: 2019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t
• 00852282007037 - HEATmarker® Time-Temperature Indicators: F12: 2019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t
• 00852282007044 - HEATmarker® Time-Temperature Indicators: F24: 2019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t
• 00852282007051 - HEATmarker® Time-Temperature Indicators: F36: 2019-02-21 Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed t