AQUIOS B25697

GUDID 15099590225827

AQUIOS Sheath Solution

BECKMAN COULTER IRELAND INC.

Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent

• Primary Device ID: 15099590225827
• NIH Device Record Key: ac89f2bf-b861-4b57-9cad-4a293ab1b042
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUIOS
• Version Model Number: B25697
• Catalog Number: B25697
• Company DUNS: 985071975
• Company Name: BECKMAN COULTER IRELAND 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590225827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141932

FDA Product Code

• GIF: Diluent, Blood Cell

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: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [AQUIOS]

• 15099590225889: AQUIOS CL Flow Cytometer
• 15099590225841: AQUIOS Cleaning Agent
• 15099590225827: AQUIOS Sheath Solution
• 15099590225803: AQUIOS Lysing Reagent Kit
• 15099590225773: AQUIOS Sodium Hypochlorite Solution