PK7300 N3209000

GUDID 14987666535721

PK7300

Beckman Coulter, Inc.

Blood group/antibody screening analyser IVD, automated

• Primary Device ID: 14987666535721
• NIH Device Record Key: e8386ffe-003b-4d96-8e65-2dad9fceb7b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PK7300
• Version Model Number: N3209000
• Catalog Number: N3209000
• Company DUNS: 008254708
• Company Name: Beckman Coulter, 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: 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	14987666535721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK090036

FDA Product Code

• KSZ: System, Test, Automated Blood Grouping And Antibody

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: 2016-09-24

Devices Manufactured by Beckman Coulter, Inc.

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