Endogator Kit 4005472

GUDID 40677964028142

Endogator Kit includes Endogator Irrigation Tubing for Endogator EGP-100 Irrigation pump, Olympus OFP Pump, gi4000 ESU or Torrent Irrigation Pump, and ENDO SMARTCAP Rinse and insufflation Tubing for PENTAX GI Endoscopes.

MEDIVATORS INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: 40677964028142
• NIH Device Record Key: 1cfa3d46-ba33-4a40-b3b9-869141462874
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endogator Kit
• Version Model Number: 4005472
• Catalog Number: 4005472
• Company DUNS: 068199363
• Company Name: MEDIVATORS 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	40677964028135 [Primary]
GS1	40677964028142 [Package]; Contains: 40677964028135; Package: Box [10 Units]; In Commercial Distribution
GS1	40677964028159 [Package]; Contains: 40677964028135; Package: Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102855

FDA Product Code

• OCX: endoscopic irrigation/suction system

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: 2022-07-22
• Device Publish Date: 2022-07-14

On-Brand Devices [Endogator Kit]

• 20677964070468: 100658B
• 20677964070437: 100655B
• 20677964068953: 100653B
• 20677964068946: 100650B
• 20677964067383: 100623B
• 20677964067376: 100622B
• 00677964067358: 100620B
• 20677964065372: 100658
• 20677964065365: 100657
• 20677964065358: 100656
• 20677964065341: 100655
• 20677964065334: 100654
• 20677964065327: 100653
• 20677964065310: 100652
• 20677964065303: 100651
• 20677964065297: 100650
• 20677964056967: 100629
• 20677964056950: 100628
• 20677964056943: 100627
• 20677964056936: 100626
• 20677964056929: 100625
• 20677964056912: 100623
• 20677964056905: 100622
• 20677964056899: 100621
• 20677964056882: 100620
• 20677964056523: 100618
• 20677964056516: 100616
• 20677964056509: 100615
• 20677964056493: 100614
• 20677964056486: 100613
• 20677964052440: 100612
• 20677964052433: 100611
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• 10677964059640: EndoGator Hybrid Tubing Kit for use with Endogator Irrigation Pump, Olympus Pump, gi4000 ESU, an