ProChem EXT CI-EXT

GUDID M985CIEXT1

ProChem EXT chemical indicator - 250/box

MESA LABORATORIES, INC.

Biological sterilization indicator
Primary Device IDM985CIEXT1
NIH Device Record Key05d3f6cf-d742-4de3-bce1-d0a7da9db1f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameProChem EXT
Version Model NumberCI-EXT
Catalog NumberCI-EXT
Company DUNS102530326
Company NameMESA LABORATORIES, INC.
Device Count250
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM985CIEXT0 [Unit of Use]
HIBCCM985CIEXT1 [Primary]

FDA Product Code

JOJIndicator, Physical/Chemical Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2016-08-29

Devices Manufactured by MESA LABORATORIES, INC.

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M985051000T0 - Dual Spore Strips - Test2025-01-23 Mesa Labs dual species spore strips. 10e5/10e6 population. 1000 count package.
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