ZUTRON

GUDID 04961333244478

PENTAX LEAK TESTER HANDHLD

PENTAX OF AMERICA, INC.

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• Primary Device ID: 04961333244478
• NIH Device Record Key: 39c2c4ad-02e7-4623-ab9d-e3169cb22a8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZUTRON
• Version Model Number: ZUTR10002P
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, 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: 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	04961333244478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093718

FDA Product Code

• FCY: Bulb, Inflation, For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-15

On-Brand Devices [ZUTRON]

• 04961333244515: ZUTRON AUTO LEAK TESTER POWER SUPPLY
• 04961333244508: LEAK TESTER - WALL MOUNT
• 04961333244492: ZUTRON AUTOMATIC LEAK TESTER C
• 04961333244485: LEAK TESTER - COUNTER
• 04961333244478: PENTAX LEAK TESTER HANDHLD
• 04961333244461: LEAK TESTER ADAPTER