FDA.reportPublic FDA data

SteriChek® Blood Leak Reagent Strips

Primary DI
00851575007129
Brand
SteriChek® Blood Leak Reagent Strips
Company
HACH COMPANY
Model
812014
Catalog number
812145
Device description
Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodialysis procedure.
Published
2016-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FJDDetector, Leak, Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJDDetector, Leak, BloodGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042322000STERICHEK BLOOD LEAK REAGENT STRIPSHach Company2004-12-07FJD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851575007129PackageGS1324In Commercial Distribution
00851575007112PrimaryGS10
00851575007099Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851575007129008515750071298515750071290851575007129
00851575007112008515750071128515750071120851575007112
00851575007099008515750070998515750070990851575007099

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system blood leak detectorAn electrically-powered integral unit of a haemodialysis system that detects blood leaks in the effluent side of the dialysate within the system and sounds an alarm if there is blood detected on this non-blood side.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.25Inch
Width0.2Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature60 Degrees Fahrenheit90 Degrees Fahrenheit
Special Storage Condition, Specify00Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment Temperature60 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-970-278-4951etscustomerservice@hach.com

Regulatory Flags#

DUNS number
091381780
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851575007389Stericide Peroxide Reagent Strips811905B811905B2020-04-14
00851575007044SteriChek® Peroxide Reagent Strips8119058119052016-09-23
00851575007075SteriChek® Residual Peroxide Reagent Strips8119058219712016-09-23
00851575007112SteriChek® Blood Leak Reagent Strips8120148121452016-10-28
00851575007020SteriChek® Residual Chlorine Reagent Strips8119008119002016-11-23
00851575007051SteriChek® Total Chlorine Test Kit8119028119022016-11-23
00851575007068Sterichek® Total Chlorine Test Kit Refill8119028119032016-11-23
00851575007105SteriChek® Blood Leak Reagent Strips8120148120142016-10-28
00851575007143Sterichek® BiCarb pH Reagent Strips8119168119162016-10-28
00851575007150SteriChek® Peracetic Acid Reagent Strips8119068119062016-09-23
00851575007273HACH974660097466002017-05-12
00851575007181HACH973010097301002017-05-12
00851575007198HACH963860096386002017-05-12
00851575007242HACH971730097173002017-05-12
00851575007297HACH963890096389002017-05-12
00851575007310HACH974730097473002017-05-12
00851575007334HACH974740097474002017-05-12
00851575007358HACH974750097475002017-05-12
00851575007365HACH975660097566002017-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M17451191Serim® GUARDIAN™ Blood Leak Test StripsSERIM RESEARCH CORPORATIONFJD2026-01-29
M17451190Serim® GUARDIAN™ Blood Leak Test StripsSERIM RESEARCH CORPORATIONFJD2026-01-29
00858293006175EZ-ChekREPROCESSING PRODUCTS CORPORATIONFJD2017-03-07
00858293006397EZ-ChekREPROCESSING PRODUCTS CORPORATIONFJD2017-03-07
M1745119C1Serim® GUARDIAN™ Blood Leak Test StripsSERIM RESEARCH CORPORATIONFJD2017-02-12
M1745119C2Serim® GUARDIAN™ Blood Leak Test StripsSERIM RESEARCH CORPORATIONFJD2017-02-12
00851575007112SteriChek® Blood Leak Reagent StripsHACH COMPANYFJD2016-10-28
00851575007105SteriChek® Blood Leak Reagent StripsHACH COMPANYFJD2016-10-28