| Primary Device ID | 00613994870797 |
| NIH Device Record Key | 64e9b9fc-2f76-4997-84ab-7943440b08f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | NRE1004 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Width | 3.5 Centimeter |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994870797 [Primary] |
| GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00613994870797]
Moist Heat or Steam Sterilization
[00613994870797]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-05-05 |
| 20763000281643 - Donldsn | 2024-04-30 VENT TUBE 1015101 5PK DONLDSN 1.14 FLPL |
| 20763000282992 - Shah | 2024-04-29 VENT TUBE 14311 5PK MINI SHAH .76MM FLPL |
| 00763000849573 - PTEYE Parathyroid Detection System | 2024-04-12 CONSOLE PTEYE |
| 00763000849580 - PTEYE Parathyroid Detection System | 2024-04-12 CONSOLE PTEYE-RF REFURBISHED |
| 00763000882389 - NIM | 2024-02-12 EMG TUBE 8229306 NIM STD 6MM ROHS |
| 00763000882396 - NIM | 2024-02-12 EMG TUBE 8229307 NIM STD 7MM ROHS |
| 00763000882402 - NIM | 2024-02-12 EMG TUBE 8229308 NIM STD 8MM ROHS |
| 00763000882419 - NIM | 2024-02-12 EMG TUBE 8229506 NIM CONT 6MM ROHS |