| Primary Device ID | 00613994499639 |
| NIH Device Record Key | 9f45f17d-b9cd-4fe4-aeb4-bedcd5ff2771 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIM-Response® |
| Version Model Number | 8253210 |
| 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 | 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| 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 |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| 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 | 00613994499639 [Primary] |
| GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
Moist Heat or Steam Sterilization
[00613994499639]
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 | 2016-05-02 |
| 00613994858399 | PATIENT INTFC 8253200RF RESP 3.0 REFURB |
| 00613994529053 | MAINFRAME 8253002 NIM RESPONSE 3.0 INTL |
| 00613994499714 | MAINFRAME 8253001 NIM RESPONSE 3.0 |
| 00613994499639 | PATIENT INTERFACE 8253210 NIM PULSE 3.0 |
| 00613994499615 | PATIENT INTERFACE 8253200 RESPONSE 3.0 |
| 00643169871014 | MAINFRAME 8253001RF NIM RESP 3.0 REFURB |
| 00643169782549 | MAINFRAME 8253001 NIM RESP 3.0 EL ROHS |
| 00643169782488 | MAINFRAME 8253001LO NIM RESP 3.0 LOANER |
| 00643169782440 | PATIENT INTFC 8253200 RESPONSE 3.0 ROHS |
| 00643169547049 | MAINFRAME 8253001 NIM RESP 3.0 EL ROHS |
| 00643169530980 | PATIENT INTFC 8253200LO RESP 3.0 LOANER |
| 00643169530973 | MAINFRAME 8253001LO NIM RESP 3.0 LOANER |
| 00643169283275 | PATIENT INTFC 8253200 RESPONSE 3.0 ROHS |
| 00643169230392 | MAINFRAME 8253002 NIM RESP 3.0 INTL ROHS |
| 00643169230385 | MAINFRAME 8253001 NIM RESPONSE 3.0 ROHS |