ORTHO 6904630

GUDID 10758750030149

ORTHO™ Workstation ID-MTS Gel

ORTHO-CLINICAL DIAGNOSTICS, INC.

Gel column agglutination centrifuge IVD

• Primary Device ID: 10758750030149
• NIH Device Record Key: 4bf6efd8-b523-49a4-a4d9-e97781613ae4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO
• Version Model Number: 6904630
• Catalog Number: 6904630
• Company DUNS: 068715424
• Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -15 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10758750030149 [Primary]

FDA Product Code

• KSN: CENTRIFUGE, CELL-WASHING, AUTOMATED FOR IMMUNO-HEMATOLOGY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-07-20
• Device Publish Date: 2016-08-24

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