StatSpin X00-003808-001

GUDID 10873037000766

CritSpin Digital Reader

IRIS INTERNATIONAL, INC.

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