ZUTR30005

GUDID 50724995244410

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

MEDIVATORS INC.

Invasive medical device leak tester, electrical
Primary Device ID50724995244410
NIH Device Record Keyd982bfe4-a2c8-4fba-863d-e490aabf7f9a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberEndo Leak Tester
Catalog NumberZUTR30005
Company DUNS068199363
Company NameMEDIVATORS INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com
Phone+1(800)548-4873
Emailcustserv@medivators.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995244415 [Primary]
GS150724995244410 [Package]
Contains: 00724995244415
Package: Case [3 Units]
In Commercial Distribution

FDA Product Code

FCYBulb, inflation, for endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-18
Device Publish Date2025-06-10

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