StatSpin X00-003808-001

GUDID 10873037000766

CritSpin Digital Reader

IRIS INTERNATIONAL, INC.

Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD

• Primary Device ID: 10873037000766
• NIH Device Record Key: 65a14310-7a9c-4447-89ad-3767bcd8631f
• Commercial Distribution Discontinuation: 2022-12-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: StatSpin
• Version Model Number: X00-003808-001
• Catalog Number: X00-003808-001
• Company DUNS: 098240690
• Company Name: IRIS INTERNATIONAL, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	10873037000766 [Primary]

FDA Product Code

• JPI: Device, Hematocrit Measuring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-09-08
• Device Publish Date: 2016-09-24

On-Brand Devices [StatSpin]

• 10873037000216: StatSpin MP Multipurpose Centrifuge
• 10873037000766: CritSpin Digital Reader