ZUTR30005KITO

GUDID 00724995360214

Endo Leak Kit contains Endo Leak Tester, Olympus Adapter, Calibration Adapter, Calibration Gauge, and power supply.

MEDIVATORS INC.

Invasive medical device leak tester, electrical

• Primary Device ID: 00724995360214
• NIH Device Record Key: 0458d69e-45ae-4b2d-9cf2-f8452761f89b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Endo Leak Tester Kit-4010827
• Catalog Number: ZUTR30005KITO
• Company DUNS: 068199363
• Company Name: MEDIVATORS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995360214 [Primary]

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: 1
• Public Version Date: 2026-02-12
• Device Publish Date: 2026-02-04

Devices Manufactured by MEDIVATORS INC.

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• 00724995360214 - NA: 2026-02-12Endo Leak Kit contains Endo Leak Tester, Olympus Adapter, Calibration Adapter, Calibration Gauge, and power supply.
• 00724995360214 - NA: 2026-02-12 Endo Leak Kit contains Endo Leak Tester, Olympus Adapter, Calibration Adapter, Calibration Gauge, and power supply.
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• 00724995360238 - NA: 2026-02-12 Endo Leak Kit contains Endo Leak Tester, Storz Adapter, Calibration Adapter, Calibration Gauge, and power supply.
• 00724995360245 - NA: 2026-02-12 Endo Leak Kit contains Endo Leak Tester, Wolf Adapter, Calibration Adapter, Calibration Gauge, and power supply.
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• 50677964151908 - Endo Carry-on Procedure Kit: 2026-02-09 Endo Carry-on Procedure Kit contains Intercept Bedside Kit, VIA Enzymatic Sponge, Defendo Olympus 4-Piece Kit, Transport Pad, Ga