SteriChek® Blood Leak Reagent Strips 812145

GUDID 00851575007129

Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodialysis procedure.

HACH COMPANY

Haemodialysis system blood leak detector
Primary Device ID00851575007129
NIH Device Record Key99ff205b-df4a-4d56-aaec-96150a9ec45a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriChek® Blood Leak Reagent Strips
Version Model Number812014
Catalog Number812145
Company DUNS091381780
Company NameHACH COMPANY
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-970-278-4951
Emailetscustomerservice@hach.com

Device Dimensions

Length3.25 Inch
Length3.25 Inch

Operating and Storage Conditions

Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851575007099 [Unit of Use]
GS100851575007112 [Primary]
GS100851575007129 [Package]
Contains: 00851575007112
Package: Case [324 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FJDDetector, Leak, Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-12
Device Publish Date2016-10-28

On-Brand Devices [SteriChek® Blood Leak Reagent Strips]

00851575007129Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodia
00851575007105Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodia

Trademark Results [SteriChek]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STERICHEK
STERICHEK
76205017 2658130 Live/Registered
Hach Company
2001-02-02
STERICHEK
STERICHEK
75353982 not registered Dead/Abandoned
Environmental Test Systems, Inc.
1997-09-09

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