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E006-059

SF - Immunization Devices
Download file
E006-059.pdf
E006-059.json
Product Details
Product name
HEATmarker® VVM+250
IMD-PQS Code
E006-059
Status
Prequalified
Date of acceptance
28 Mar 2019
Appliance type
E006
Product description
Combined VVM250 and Threshold Indicator40
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
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
Fixing mechanism
None
CE marking
Yes
Time to endpoint at 37°C (days)
250.00
Time to endpoint at 25°C (days)
900.00
Time to endpoint at 5°C (days)
10000.00

Mechanical and electronic devices only

Power source
Passive device
Alarm type
NA
Display medium
Color change
Recording medium
Not applicable
Comments
The VVM+ Indicator is a single-use, self-adhesive combined indicator that contains an active surface that signals by an irreversible color change from light to dark when either the defined threshold temperature profile has been exceeded or the cumulative heat exposure have been exceeded. Dots (on a clear 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.

Standard Label Size: 10.5 mm dot (circle)
Indicators per Roll: 10,000 (standard)

Price and shipping

Minimum order
50000.00
Incoterms
EXW
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/IN06.1
Applicable PQS VP(s): E006/IN06-VP.1

Verification

Verification Laboratory
0013X00004Ml8OlQAJ
Verification Report Reference
LLTPL/TL/2018-02
LLTPL/TL/2018-03
Product Sites
Temptime Corporation, A Zebra Technologies Company
116 American Road, Morris Plains, NJ, 07950, United States
United States of America
Document Details