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E006-058

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
Zebra Technologies International
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
Telephone
+1 973 630 6000
Valid until
31 May 2026
Specifications

Product specifications - Main

Mode of operation
Chemical
External dimensions height (mm)
10.00
Activation mechanism
Always active
VVM Type
VVM250
Fixing mechanism
Adhesive
Time to endpoint at 37°C (days)
250.00
Comments
Vaccine Vial Monitor Type 250 Dote (on clear or brown liner) are made from 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.

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

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/IN05.4
Applicable PQS VP(s): E003/IN05-VP.4

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/2018-02
Product Sites
Zebra Technologies International
116 American Road, Morris Plains, NJ, 07950, United States
United States of America
Document Details