ISE Diluent

GUDID 00811403018338

Diamond Diagnostics Inc.

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