FDA.reportPublic FDA data

HEATmarker® Time-Temperature Indicators: CT12

Primary DI
00852282007129
Brand
HEATmarker® Time-Temperature Indicators: CT12
Company
Temptime Corporation
Model
CT12
Device description
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 22.5°C.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852282007129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852282007129008522820071298522820071290852282007129

GMDN Terms#

Term, Definition table
TermDefinition
Medical product temperature point indicator, thermochemicalA 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
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-24 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
973-630-6000info@temptimecorp.com

Regulatory Flags#

DUNS number
152578522
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10852282007140Safe-T-Vue 10STV107201-502019-10-29
20852282007147Safe-T-Vue 10STV107201-502019-10-29
10852282007157Safe-T-Vue 6STV67206-502019-10-29
00852282007006HEATmarker® Time-Temperature Indicators: F3F32016-09-23
00852282007013HEATmarker® Time-Temperature Indicators: F6F62016-09-23
00852282007020HEATmarker® Time-Temperature Indicators: F9F92016-09-23
00852282007037HEATmarker® Time-Temperature Indicators: F12F122016-09-23
00852282007044HEATmarker® Time-Temperature Indicators: F24F242016-09-23
00852282007051HEATmarker® Time-Temperature Indicators: F36F362016-09-23
00852282007068HEATmarker® Time-Temperature Indicators: CT2CT22016-09-23
00852282007075HEATmarker® Time-Temperature Indicators: CT3CT32016-09-23
00852282007082HEATmarker® Time-Temperature Indicators: CT4CT42016-09-23
00852282007099HEATmarker® Time-Temperature Indicators: CT6CT62016-09-23
00852282007105HEATmarker® Time-Temperature Indicators: CT9CT92016-09-23
00852282007112HEATmarker® Time-Temperature Indicators: CT24CT242016-09-23
00852282007136HEATmarker® Time-Temperature Indicators: CT36CT362016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D771604291Dental CityICP, INC.JOJ2026-05-27
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07798375772891VERISURE™TERRAGENE S.A.JOJ2024-11-12