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 ID: 00851575007129
• NIH Device Record Key: 99ff205b-df4a-4d56-aaec-96150a9ec45a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriChek® Blood Leak Reagent Strips
• Version Model Number: 812014
• Catalog Number: 812145
• Company DUNS: 091381780
• Company Name: HACH COMPANY
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-970-278-4951
• Email: etscustomerservice@hach.com

Device Dimensions

• Length: 3.25 Inch
• Length: 3.25 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851575007099 [Unit of Use]
GS1	00851575007112 [Primary]
GS1	00851575007129 [Package]; Contains: 00851575007112; Package: Case [324 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042322

FDA Product Code

• FJD: Detector, Leak, Blood

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2016-10-28

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

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