ISOFLOW SHEATH FLUID 8546859

GUDID 15099590250935

IsoFlow Sheath Fluid

Beckman Coulter, Inc.

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

• Primary Device ID: 15099590250935
• NIH Device Record Key: 96b85906-3e11-4af1-a753-2105f8f1032a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISOFLOW SHEATH FLUID
• Version Model Number: 8546859
• Catalog Number: 8546859
• Company DUNS: 008254708
• Company Name: Beckman Coulter, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590250935 [Primary]

FDA Product Code

• GIF: Diluent, Blood Cell

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: 2019-03-11
• Device Publish Date: 2019-02-15

On-Brand Devices [ISOFLOW SHEATH FLUID]

• 15099590542313: IsoFlow Sheath Fluid
• 15099590250935: IsoFlow Sheath Fluid