ZUTRON

GUDID 04961333244492

ZUTRON AUTOMATIC LEAK TESTER C

PENTAX OF AMERICA, INC.

Endoscope leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical Invasive medical device leak tester, electrical

• Primary Device ID: 04961333244492
• NIH Device Record Key: 36159300-4ef2-4891-a44d-10effb64b3a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZUTRON
• Version Model Number: ZUTR10003TG
• 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	04961333244492 [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