Sterichek® BiCarb pH Reagent Strips

Primary DI
00851575007143
Brand
Sterichek® BiCarb pH Reagent Strips
Company
HACH COMPANY
Model
811916
Catalog number
811916
Device description
Reagent test strip used to measure hydrogen ion concentration (pH) in bicarbonate buffer
Published
2016-10-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNVStrip, Dialysate Ph Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNVStrip, Dialysate Ph IndicatorGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031267000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031267000STERICHEK BICARB PH REAGENT STRIPSEnvironmental Test Systems, Inc.2003-12-23MNV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851575007143PrimaryGS10
00851575007136Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851575007143008515750071438515750071430851575007143
00851575007136008515750071368515750071360851575007136

GMDN Terms#

Term, Definition table
TermDefinition
pH meter IVDA manual, semi-automated, or automated instrument intended to be used for the qualitative and/or quantitative in vitro determination of the pH of a clinical specimen (i.e., its degree of acidity or alkalinity) by measuring hydrogen ion concentration.

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
500
Lot or batch
true
Expiration date on label
true

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
00851575007150SteriChek® Peracetic Acid Reagent Strips8119068119062016-09-23
00851575007129SteriChek® Blood Leak Reagent Strips8120148121452016-10-28
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
00858293006137EZ-ChekREPROCESSING PRODUCTS CORPORATIONMNV2017-03-07
00858293006144EZ-ChekREPROCESSING PRODUCTS CORPORATIONMNV2017-03-07
00858293006151EZ-ChekREPROCESSING PRODUCTS CORPORATIONMNV2017-03-07
00858293006168EZ-ChekREPROCESSING PRODUCTS CORPORATIONMNV2017-03-07
00858293006373E-Z ChekREPROCESSING PRODUCTS CORPORATIONMNV2017-03-07
M1745116A1Serim® GUARDIAN™ Bicarb pH II Test Strips SERIM RESEARCH CORPORATIONMNV2016-09-19
M1745116B1Serim® GUARDIAN™SERIM RESEARCH CORPORATIONMNV2016-08-29