Alinity mp 09N65-005

GUDID 00884999048959

Alinity mp SurePath Holder, Replacement

ABBOTT MOLECULAR INC.

Instrument/analyser specimen/reagent container carrier IVD

• Primary Device ID: 00884999048959
• NIH Device Record Key: 47d76484-da34-432f-872b-c3f695cc78c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alinity mp
• Version Model Number: 09N65-005
• Catalog Number: 09N65-005
• Company DUNS: 878263359
• Company Name: ABBOTT MOLECULAR 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999048959 [Primary]

FDA Product Code

• JQW: STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

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: 2024-05-03
• Device Publish Date: 2024-04-25

On-Brand Devices [Alinity mp]

• 00884999048911: Alinity mp System
• 00884999048980: 09N65-008
• 00884999048959: Alinity mp SurePath Holder, Replacement
• 00884999048942: Alinity mp Exception Rack, Replacement
• 00884999048935: Alinity mp Vial Input Rack Replacement
• 00884999048928: 09N65-002