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E006-001

SF - Immunization Devices
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E006-001.pdf
E006-001.json
Product Details
Product name
HEATmarker® VVM 2
IMD-PQS Code
E006-001
Status
Prequalified
Date of acceptance
30 Sep 2007
Appliance type
E006
Product description
Vaccine Vial Monitor Type 2
Manufacturer
Temptime Corporation, A Zebra Technologies Company
Manufacturer Reference
HEATmarker® VVM 2
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
Email
rorie.doty@zebra.com
Website address
www.zebra.com/tempmonitoring
Valid until
31 May 2026
Specifications

Product specifications - Main

Mode of operation
Chemical
Sensor type(s)
--
Maximum sensor lead length (metres)
0.00
Maximum number of sensor channels
0.00
Activation mechanism
Temperature >-12°C
Fixing mechanism
Adhesive
CE marking
No
Time to endpoint at 37°C (days)
2.00
Time to endpoint at 5°C (days)
225.00

Mechanical and electronic devices only

Power source
Passive device
Battery type
--
Battery shelf life (year)
--
Activated battery life
--
Alarm type
NA
User interface
--
Display medium
Color change
Recording medium
Not applicable
Ingress protection rating IP
--
Comments
Full labels (typically white of clear liner) and dots (typically brown or clear liner) are made on lightweight litho/paper/film facestock offering exceptional printability and
flexibility. The service temperature range for the adhesive is typically -40°F to 160°F, or wider. Liner (can either be PET or coated paper) is designed for high-speed
roll-to-roll and label dispensing applications. A clear film-based over-laminate is used for dots (brown liner) for added stability and protection. This laminate is not
intended to print on.
Custom solutions, including a combination of approved litho/paper/film substrate and overlaminate (if applicable) are available upon request.

Verification laboratory: Intertek UK (formerly WHO-accredited)

Accuracy: --
External dimensions (cm): 1 cm dot or 1.6 x 1.0 cm rectangle
Memory size: --
External dimensions (cm): 1 cm dot or 1.6 x 1.0 cm rectangle

Price and shipping

Minimum order
500000.00
Incoterms
EXW
Price 1
On request to manufacturer
Year of base price
2017

Quality standard

Quality Standard
ISO 13485;Other
Quality standard (Other)
ISO 9001:2015;
Specification Reference
Applicable PQS specification: E006/IN.05.1
Applicable PQS VP(s): E006/IN.05 VP.1

Verification

Verification Report Reference
A65155
Product Sites
Temptime Corporation, A Zebra Technologies Company
116 American Road, Morris Plains, NJ, 07950, United States
United States of America
Document Details