ISE Wash Solution Kit

GUDID 00811403011735

Diamond Diagnostics Inc.

Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system Wash/cleaning solution IVD, automated/semi-automated system

• Primary Device ID: 00811403011735
• NIH Device Record Key: 44846f5a-c2b3-4f3a-81b8-5cb0f2beb3a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISE Wash Solution Kit
• Version Model Number: BT-6620940SD
• 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	00811403011735 [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