Zenition 718133

GUDID 00884838091528

The Zenition 70 with flat detector is a mobile X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed

Philips Medical Systems Nederland B.V.

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• Primary Device ID: 00884838091528
• NIH Device Record Key: 4109ad36-2f1b-4218-a8cd-04f43dbb9105
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zenition
• Version Model Number: Zenition 70
• Catalog Number: 718133
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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: false
• 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	00884838091528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183040

FDA Product Code

• OXO: Image-Intensified Fluoroscopic X-Ray System, Mobile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-23
• Device Publish Date: 2019-04-04

On-Brand Devices [Zenition]

• 00884838091535: The Zenition 50 with image intensifier is a mobile X-ray imaging and viewing system. It is desig
• 00884838091528: The Zenition 70 with flat detector is a mobile X-ray imaging and viewing system. It is designed