| 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 |
| 00763000309480 - Causse/Polycel | 2025-07-01 PROSTHESIS 1156376 CAUSSE FLPL PARTIAL |
| 20763000870359 - Microgel | 2025-07-01 VENT TUBE 1082201 5PK PAPA TYPE 1.14 |
| 20763000870366 - Sheehy | 2025-07-01 VENT TUBE 1083301 5PK SHEEHY TYPE 1.27 |
| 20763000870373 - 20763000870373 | 2025-07-01 VENT TUBE 1084401 5PK GROMMET 1.27 |
| 20763000870380 - Reuter | 2025-07-01 VENT TUBE 1010201 5PK BOBBIN 1.14 FLPL |
| 20763000870403 - Sheehy | 2025-07-01 VENT TUBE 1013301 5PK BUTTON 1.27 FLPL |
| 20763000870410 - Donaldson | 2025-07-01 VENT TUBE 1015101 5PK DONLDSN 1.14 FLPL |
| 20763000870427 - Shepard | 2025-07-01 VENT TUBE 1016101 5PK GROMMET 1.14 FLPL |