SF - Immunization Devices
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Product Details
Product name
HEATmarker® VVM 250
IMD-PQS Code
E006-058
Status
Prequalified
Date of acceptance
27 Mar 2019
Appliance type
E006
Product description
Vaccine Vial Monitor Type 250
Manufacturer
Temptime Corporation, A Zebra Technologies Company
Manufacturer Reference
HEATmarker® VVM 250
Country of Manufacture
United States of America
Address
116 American Road, Morris Plains, NJ, 07950, United States
United States of America
United States of America
Telephone
+1 973 630 6000
Email
Website address
Valid until
31 May 2026
Specifications
Product specifications - Main
Mode of operation
Chemical
Fixing mechanism
None
CE marking
Yes
Time to endpoint at 37°C (days)
250.00
Time to endpoint at 25°C (days)
900.00
Mechanical and electronic devices only
Power source
Passive device
Alarm type
NA
Display medium
Color change
Recording medium
Not applicable
Price and shipping
Minimum order
50000.00
Incoterms
EXW
Year of base price
2019
Quality standard
Quality Standard
ISO 13485;Other
Quality standard (Other)
ISO 9001:2015
Specification Reference
Applicable PQS specification: E006/IN05.3
Applicable PQS VP(s): E003/IN05-VP.3
Applicable PQS VP(s): E003/IN05-VP.3
Verification
Verification Laboratory
0013X00004Ml8OlQAJ
Verification Report Reference
LLTPL/TL/2018-02
Product Sites
Temptime Corporation, A Zebra Technologies Company
116 American Road, Morris Plains, NJ, 07950, United States
United States of America
Document Details
Dots (*on clear or brown liner) are made on film facestock. The service temperature range for the adhesive is typically -40°F to 200°F, or wider. Liner PET is designed for high speed roll-to-roll and label dispensing applications.
Custom solutions including a combination of approved litho/paper/film substrate and over-laminate (if applicable) are available upon request.
Note:
- Time to endpoint at 25°C (days): > 900 days
- Time to endpoint - VVM (Arrhenius) reaction rates determined at 55°C and 45°C; the values are approximate
External dimensions (cm): 0