PENTRA C400 ISE

GUDID 03610230006559

PENTRA C400 ISE (110V)

HORIBA ABX SAS

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• Primary Device ID: 03610230006559
• NIH Device Record Key: 1a15c6e3-e69d-43ba-b2e2-277f06e3207e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PENTRA C400 ISE
• Version Model Number: 1280030006
• Company DUNS: 273647420
• Company Name: HORIBA ABX SAS
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610230006559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052007

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2019-12-23
• Device Publish Date: 2016-09-02

On-Brand Devices [PENTRA C400 ISE]

• 03610230006757: PENTRA C400 ISE (110V)
• 03610230006559: PENTRA C400 ISE (110V)