| Primary Device ID | 50724995244458 |
| NIH Device Record Key | b10cd2a7-8331-4537-81a4-9be06e129aa1 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | Endo Leak Tester Adapter |
| Catalog Number | ZUTR10005O |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +1(800)548-4873 |
| custserv@medivators.com | |
| Phone | +1(800)548-4873 |
| custserv@medivators.com | |
| Phone | +1(800)548-4873 |
| custserv@medivators.com | |
| Phone | +1(800)548-4873 |
| custserv@medivators.com | |
| Phone | +1(800)548-4873 |
| custserv@medivators.com | |
| Phone | +1(800)548-4873 |
| custserv@medivators.com | |
| Phone | +1(800)548-4873 |
| custserv@medivators.com | |
| Phone | +1(800)548-4873 |
| custserv@medivators.com | |
| Phone | +1(800)548-4873 |
| custserv@medivators.com | |
| Phone | +1(800)548-4873 |
| custserv@medivators.com | |
| Phone | +1(800)548-4873 |
| custserv@medivators.com | |
| Phone | +1(800)548-4873 |
| custserv@medivators.com | |
| Phone | +1(800)548-4873 |
| custserv@medivators.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00724995244453 [Primary] |
| GS1 | 50724995244458 [Package] Contains: 00724995244453 Package: Case [50 Units] In Commercial Distribution |
| FCY | Bulb, inflation, for endoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-18 |
| Device Publish Date | 2025-06-10 |
| 00724995360191 - NA | 2026-02-12 Endo Leak Kit contains Endo Leak Tester, ACMI Adapter, Calibration Adapter, Calibration Gauge, and power supply. |
| 00724995360207 - NA | 2026-02-12 Endo Leak Kit contains Endo Leak Tester, Fujifilm 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. |
| 00724995360221 - NA | 2026-02-12 Endo Leak Kit contains Endo Leak Tester, Pentax Adapter, Calibration Adapter, Calibration Gauge, and power supply. |
| 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. |
| 50677964151892 - Endo Carry-on Procedure Kit | 2026-02-09 Endo Carry-on Procedure Kit contains Basin, VIA Enzymatic Sponge, Defendo Olympus 5-Piece Kit, Transport Pad, Gauze, Lubricant, |
| 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 |