FDA.reportPublic FDA data

ProChek S

Primary DI
H816TSI4401
Brand
ProChek S
Company
CERTOL INTERNATIONAL, LLC
Model
TSI440
Catalog number
TSI440-1
Device description
Steam Sterilization Integrators
Published
2016-09-23
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
K060103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060103000ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORSAlbert Browne , Ltd.2006-03-07JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H816TSI4402PackageHIBCC6In Commercial Distribution
H816TSI4401PrimaryHIBCC0
H816TSI4400Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
095153714
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H816SM43401ProChek IDSM4340SM4340-12016-09-23
H816QEZ21QEZQEZ2QEZ22023-06-02
H816QEZ22QEZQEZ2QEZ22023-06-02
H816BB0312H1BarrierBB-0312HBB-0312H-12017-01-13
H816BB0528X1BARRIERBB-0528XBB-0528X-12016-09-23
H816BB2930C1BarrierBB-2930CBB-2930C-12016-09-23
H816DC0115S1BarrierDC-0115SDC-0115S-12016-09-23
H816PFL0081ShieldPFL008PFL008-12016-09-23
H816PFLEL81ShieldPFLEL8PFLEL8-12016-09-23
H816PIT1001ProChek IDPIT100PIT100-12016-09-23
H816PM24401ProView plusPM2440PM2440-12016-09-23
H816PM27901ProView plusPM2790PM2790-12016-09-23
H816PM35541ProView plusPM3554PM3554-12016-09-23
H816PM35901ProView PlusPM3590PM3590-12016-09-21
H816PM54101ProView plusPM5410PM5410-12016-09-23
H816PM75131ProView plusPM7513PM7513-12016-09-23
H816PNS1001ProTectorPNS100PNS100-12016-09-23
H816VC3380V-CideVC338VC338-12016-09-23
H816PIT1201ProChek IDPIT120PIT120-12016-09-23
H816PIT3401ProChek IDPIT340PIT340-12017-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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