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E006-057

SF - Immunization Devices
Download file
E006-057.pdf
E006-057.json
Product Details
Product name
LIMITmarker ® I-K
IMD-PQS Code
E006-057
Status
Prequalified
Date of acceptance
27 Mar 2019
Appliance type
E006
Product description
Threshold Indicator40
Manufacturer
Temptime Corporation, A Zebra Technologies Company
Manufacturer Reference
LIMITmarker ® I-K
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

Mechanical and electronic devices only

Alarm type
NA
Recording medium
Not applicable
Comments
* LIMITmarker I-K Threshold Indicator is a single-use self-adhesive indicator that contains an active surface that signals by an irreversible color change from light to dark when the threshold temperature has been exceeded. LIMITmarker I-K Indicator dots (typically on a clear liner) are made on film facestock. The service temperature range for the adhesive is typically -40°C to 93°C. 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
Year of base price
2019

Quality standard

Quality Standard
ISO 13485;Other
Quality standard (Other)
ISO 9001:2015
Specification Reference
Applicable PQS specification: PQS/E006/IN04.1
Applicable PQS VP(s): E006/IN04-VP.1

Verification

Verification Report Reference
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