ISE Internal Reference Solution

GUDID 00811403012732

To correct for drift due to junction potential; electrode condition between samples.

Diamond Diagnostics Inc.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

• Primary Device ID: 00811403012732
• NIH Device Record Key: 80b19057-5767-41b3-a2d2-6ce5c37c4c88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISE Internal Reference Solution
• Version Model Number: BM-836246D
• Company DUNS: 947514303
• Company Name: Diamond Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811403012732 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [ISE Internal Reference Solution]

• 00811403012732: To correct for drift due to junction potential; electrode condition between samples.
• 00811403012589: BM-450042D