ISE Diluent

GUDID 00811403018338

Diamond Diagnostics Inc.

Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD

• Primary Device ID: 00811403018338
• NIH Device Record Key: e651638a-4bff-48b4-8c46-36c55ebd62bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISE Diluent
• Version Model Number: RO-4522630D
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811403018338 [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: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [ISE Diluent]

• 00811403018338: RO-4522630D
• 00811403012718: To dilute samples for Na+, K+, and Cl- measurements.
• 00811403012701: To dilute samples for Na+, K+, and Cl- measurements.
• 00811403012596: BM-450043D