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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
Zebra Technologies International
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 length (mm)
20.00
External dimensions width (mm)
29.00
Activation mechanism
Always Active
VVM Type
FREEZEmarker
Fixing mechanism
Adhesive
Comments
The FREEZEmarker® Indicator is designed as a single-use self-adhesive indicator that provides and 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. 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 insode the blister. The surface to which the FREEZEmarker can be applied (carton, card, glass, etc) must be above 2°C (35.6°F). Standard backing cards with an indicator applied are 86mm x 54mm and provided in boxes of 200. Specification:-0.5°C ±1°C, 60 minutes (maximum).

Specification: -0.5°C ± 1°C, 60 minutes (maximum)
Minimum order: 1 roll
Indicators per Roll: 1,000 (standard)
Response temperature: -0.5°C

Price and shipping

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

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): PQS/E006/IN07.VP.1

Verification

Verification Laboratory
Lisaline Lifescience Technologies PVT. LTD
Address
401-D WI FI Park, Plot No B-3, Road No 1, Wagle Ind. Estate, Thane Maharashtra- 400604, India
India
Telephone
+917506044908
Verification Report Reference
LLTPL/TL/2019-02
Product Sites
Zebra Technologies International
116 American Road, Morris Plains, NJ, 07950, United States
United States of America
Document Details