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E006-067

SF - Immunization Devices
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Product Details
Product name
FREEZEmarker® L
IMD-PQS Code
E006-067
Status
Prequalified
Date of acceptance
08 May 2020
Appliance type
E006
Product description
Chemical Freeze Indicator
Manufacturer
Temptime Corporation, A Zebra Technologies Company
Manufacturer Reference
FREEZEmarker® L
Country of Manufacture
United States of America
Address
116 American Road, Morris Plains, NJ, 07950, United States
United States of America
Telephone
+1 973 630 6000
Valid until
31 May 2026
Specifications

Product specifications - Main

Mode of operation
Chemical
External dimensions height (mm)
20.00
External dimensions width (mm)
29.00
Fixing mechanism
Adhesive
CE marking
Yes

Mechanical and electronic devices only

Power source
Passive device
Alarm type
NA
Display medium
Color Change Indicator
Recording medium
Not applicable
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
Indicators per Roll: 1,000 (standard)

Price and shipping

Minimum order
1.00
Price 1
On request to manufacturer

Quality standard

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

Verification

Verification Laboratory
0013X00004Ml8OlQAJ
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