FDA.reportPublic FDA data

ProChek ID

Primary DI
H816PIT3401
Brand
ProChek ID
Company
CERTOL INTERNATIONAL, LLC
Model
PIT340
Catalog number
PIT340-1
Device description
Steam Sterilization Indicator Tape
Published
2017-01-13
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
LRTIndicator, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRTIndicator, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951113000CROSS-CHECKSSteritec Products Mfg Co, Inc.1996-08-19LRT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H816PIT3402PackageHIBCC12In Commercial Distribution
H816PIT3401PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging tapeA non-sterile, flexible, band (typically made of paper) coated on one side with a pressure-sensitive adhesive, used to seal packages of instruments, utensils, or medical devices that are wrapped in drapes or sterilization packaging, prior to being sterilized in the hospital or other facility. This device will typically have indicators on its non-adhesive side that darken to indicate that the package has been sterilized. It typically comes in rolls in a variety of widths. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
095153714
Device count
1
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
H816TSI4401ProChek STSI440TSI440-12016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818087010952"Gas-Chex EO Gas 3/4"" Indicator Tape"PROPPER MANUFACTURING COMPANY, INC.LRT2023-06-16
H816MSM43401ProCheck IDMicroCare, LLCLRT2022-10-26
H816MSM43402ProCheck IDMicroCare, LLCLRT2022-10-26
10080196479009MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.LRT2022-03-23
40080196479000MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.LRT2022-03-23
30080196729580MedlineMEDLINE INDUSTRIES, INC.LRT2021-01-26
10080196729586MedlineMEDLINE INDUSTRIES, INC.LRT2021-01-26
10080196756988MedlineMEDLINE INDUSTRIES, INC.LRT2021-01-02
30080196756982MedlineMEDLINE INDUSTRIES, INC.LRT2021-01-02
10080196756995MedlineMEDLINE INDUSTRIES, INC.LRT2020-12-31
20080196756992MedlineMEDLINE INDUSTRIES, INC.LRT2020-12-31
70818087013412"Propper 1"" Gas-Chex Sterilization Tape"PROPPER MANUFACTURING COMPANY, INC.LRT2020-03-04
10818087013410Propper 1" Gas-Chex Sterilization TapePROPPER MANUFACTURING COMPANY, INC.LRT2020-03-04
00814434021193Getinge Assured Steam Sterilization IndicatorSTERITEC PRODUCT MFG. CO., INC.LRT2019-06-10
00814434021209Getinge Assured Steam Sterilization IndicatorSTERITEC PRODUCT MFG. CO., INC.LRT2019-06-10
20814434021197Getinge Assured Steam Sterilization IndicatorSTERITEC PRODUCT MFG. CO., INC.LRT2019-06-10
20814434021203Getinge Assured Steam Sterilization IndicatorSTERITEC PRODUCT MFG. CO., INC.LRT2019-06-10
70818087011920"Propper Gas-Chex EO Gas 3/4"" Indicator Tape"PROPPER MANUFACTURING COMPANY, INC.LRT2018-09-26
30818087011960Propper Gas-Chex Indicator StripsPROPPER MANUFACTURING COMPANY, INC.LRT2017-10-04
30818087011977Propper Gas-Chex Indicator StripsPROPPER MANUFACTURING COMPANY, INC.LRT2017-10-04
30818087012936Propper Steri-Dot IndicatorsPROPPER MANUFACTURING COMPANY, INC.LRT2017-10-04
30818087012943Propper Steri-Dot IndicatorsPROPPER MANUFACTURING COMPANY, INC.LRT2017-10-04
H816PIT1001ProChek IDCERTOL INTERNATIONAL, LLCLRT2016-09-23
H816SM43401ProChek IDCERTOL INTERNATIONAL, LLCLRT2016-09-23
20885380112147CARDINAL HEALTHCardinal Health 200, LLCLRT2016-09-23
20885380112529CARDINAL HEALTHCardinal Health 200, LLCLRT2016-09-23
H816PIT1002ProChek IDCERTOL INTERNATIONAL, LLCLRT2016-09-23
H816PIT1201ProChek IDCERTOL INTERNATIONAL, LLCLRT2016-09-23
H816SM43402ProChek IDCERTOL INTERNATIONAL, LLCLRT2016-09-23
50885380112148CARDINAL HEALTHCardinal Health 200, LLCLRT2016-09-23