AccessGUDID - DEVICE: HEATmarker® Time-Temperature Indicators: F12 (00852282007037)

GUDID

Device Identifier (DI) Information

Brand Name: HEATmarker® Time-Temperature Indicators: F12
Version or Model: F12
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Temptime Corporation

Primary DI Number: 00852282007037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 152578522 *Terms of Use

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 5°C.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60964	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOJ	Indicator, Physical/Chemical Sterilization Process

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than -24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 37e938d6-a618-4e5b-8fd7-9d7515255f76
Public Version Date: February 21, 2019
Public Version Number: 3
DI Record Publish Date: September 23, 2016