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E006-067

SF - Immunization Devices
Product Details
WHO Product ID
E006-067
Status
Prequalified
Date of acceptance
Type
E006: Temperature monitoring devices
Product Desc
Chemical Freeze Indicator
Appliance Type
E006
Manufacturer
Temptime Corporation, A Zebra Technologies Company
116 American Road, Morris Plains, NJ, 07950, United States
United States of America
Valid until
Specifications

Product identification

Manufacturers Reference
FREEZEmarker® L
Country of Manufacture
United States of America

Product specifications - Main

Mode of operation
Chemical
External dimensions height (mm)
20.00
External dimensions width (mm)
29.00
Comments
The FREEZEmarker® Indicator is designed as a single-use self-adhesive indicator that provides an easy-to-read visual signal when there has been exposure to a freeze event. They can be ordered on rolls for label dispensing applications, or on a backing card. The TransTracker® backing card is an example of a single-use unit for monitoring temperature during transportation or short-term storage. The visible surface of the freeze indicator contains an area of color-changing liquid encapsulated in a blister. The FREEZEmarker varies in appearance: Before a Freeze Event, it is a clear liquid covering a green circle with a white checkmark inside the circle; at the Endpoint after a Freeze Event, the liquid will partially or completely change to appear white opaque/cloudy inside the blister. If uncertain whether the Endpoint has been reached, press the Active Zone with your fingertips to evenly distribute the white particles.
The surface to which the FREEZEmarker will be applied (carton, card, glass, etc.) must be above 2°C (35.6°F).
Standard backing cards with an indicator applied are 86 mm x 54 mm and provided in boxes of 200.

Specification: -0.5°C ± 1°C, 60 minutes (maximum)
Minimum order: 1 roll

Mechanical and electronic devices only

Power source
Passive device
Display medium
Color Change Indicator
Alarm type
NA

Price and shipping

Price 1
On request to manufacturer
Year of base price
2020
Minimum order
1.00

Quality standard

Quality Standard
ISO 13485;Other
Specification Reference
Applicable PQS specification: PQS/E006/IN07.1
Applicable PQS VP(s):
Quality standard (Other)
ISO 9001:2015

Verification

Verification Report Reference
LLTPL/TL/2019-02
Product Sites
Temptime Corporation, A Zebra Technologies Company
116 American Road, Morris Plains, NJ, 07950, United States
United States of America
Document Details