FDA.reportPublic FDA data

Mesa Labs Dry Heat Indicator Labels

Primary DI
M985CIDHI1
Brand
Mesa Labs Dry Heat Indicator Labels
Company
MESA LABORATORIES, INC.
Model
CI-DHI
Catalog number
CI-DHI
Device description
Dry Heat Indicator Labels - 1000 labels per roll, 10 rolls per pack
Published
2016-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953122000STERITEC DRY HEAT INDICATOR LABELSteritec Products Mfg Co, Inc.1997-04-02JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M985CIDHI2PackageHIBCC100In Commercial Distribution
M985CIDHI1PrimaryHIBCC0
M985CIDHI0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Regulatory Flags#

DUNS number
102530326
Device count
1000
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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M9850161001Spore Strip - EO/Dry Heat10e61-61002025-01-15
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M9850351001Spore Strip Steam & Chemiclave10e53-51002025-01-15
M9850361001Spore Strip Steam & Chemiclave10e63-61002025-01-15
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M985051000T1Dual Spore Strips - Test10e5, 10e65-1000T2025-01-15
M985055100T1Dual Spore Strip - Test10e5, 10e65-5100T2025-01-15
M9850141000Spore Strip10e41-41002025-01-15
M9850161000Spore Strip - EO/Dry Heat10e61-61002025-01-15
M9850341000Spore Strip10e43-41002025-01-15
M9850351000Spore Strip Steam & Chemiclave10e53-51002025-01-15
M9850361000Spore Strip Steam & Chemiclave10e63-61002025-01-15
M985051000C0Dual Spore Strips - Control10e5, 10e65-1000C2025-01-15
M985051000T0Dual Spore Strips - Test10e5, 10e65-1000T2025-01-15
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