ISE Buffer Kit

GUDID 00811403011766

Diamond Diagnostics Inc.

Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD

• Primary Device ID: 00811403011766
• NIH Device Record Key: 926170af-447b-477c-99d8-933574317e13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISE Buffer Kit
• Version Model Number: BT-6620942D
• Company DUNS: 947514303
• Company Name: Diamond Diagnostics Inc.
• Device Count: 6
• 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	00811403011766 [Unit of Use]
GS1	00811403011773 [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