| Primary Device ID | 00643169782495 |
| NIH Device Record Key | 0c2415a4-d7b6-4239-8543-bab478e83484 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nerve Integrity Monitor (NIM) 3.0 |
| Version Model Number | 8253200LO |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169782495 [Primary] |
| GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-05 |
| 00643169782532 | PATIENT INTFC 8253410RF NEURO 3.0 REFURB |
| 00643169782525 | PATIENT INTFC 8253410LO NEURO 3.0 LOANER |
| 00643169782501 | PATIENT INTFC 8253200RF RESP 3.0 REFURB |
| 00643169782495 | PATIENT INTFC 8253200LO RESP 3.0 LOANER |