ISE Compensator

GUDID 00811403012534

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: 00811403012534
• NIH Device Record Key: 48c0a117-88dd-4c04-b045-dce5e1f8d907
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISE Compensator
• Version Model Number: BM-1489828D
• 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	00811403012534 [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

Devices Manufactured by Diamond Diagnostics Inc.

• 00811403010158 - Photometer Lamp: 2023-06-21
• 00811403010240 - Reference Solution: 2023-06-21
• 00811403013074 - Pump Tubing Kit: 2023-06-21
• 00811403013173 - C1/C2 Cleaning Solution: 2023-06-21
• 00811403010387 - Wash Pack: 2023-06-21
• 00811403013296 - pH Electrode: 2023-06-21
• 00811403013302 - Calcium Electrode: 2023-06-21
• 00811403013319 - Potassium Electrode: 2023-06-21