| Primary Device ID | 00382830028295 |
| NIH Device Record Key | 7321fbc8-9b5f-4dab-ad4e-3cb0f9a392bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NATUS NEUROLOGY |
| Version Model Number | X1C013 |
| Company DUNS | 874257488 |
| Company Name | NATUS NEUROLOGY INCORPORATED |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382830028295 [Primary] |
| HEP | Monitor, Blood-Flow, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-15 |
| 00382830039598 | ELC/EEG SIL 6MM 1M, 12PK, DIN |
| 00382830039581 | ELC/EEG SIL 6MM 1.5M, 12PK, DIN |
| 00382830039574 | ELC/EEG GLD 6MM 1M, 12 PK, DIN |
| 00382830039567 | ELC/EEG GLD 6MM 1.5M, 12PK, DIN |
| 00382830039550 | ELC/ADAPTOR 2MM/1.5MM SOCKET |
| 00382830038638 | ALLIGATR CLP 1.25M LD 1 SET/PK |
| 00382830037952 | ELC/DIG RING REUSABLE/36" LEAD |
| 00382830037679 | PROBE 2MHZ MONITORING SONARA |
| 00382830037181 | ASSY/TCD REMOTE CONTROL ENG |
| 00382830037112 | NicoletOne V44 Amplifier |
| 00382830037068 | ASSY/TCD REMOTE CONTROL GER |
| 00382830037051 | ASSY/TCD REMOTE CONTROL RUS |
| 00382830037044 | EDX Analog Output Box and Cable |
| 00382830037037 | Stimulus Switching Pod SP1 |
| 00382830037020 | Stimulus Switching Pod SP2 |
| 00382830037013 | 10-20 Headbox for Wireless EEG Amplifier |
| 00382830037006 | 10-20 Headbox kit for Wireless EEG Amplifier |
| 00382830036993 | ASSY/EEG V44 AMP + DC OFFSET |
| 00382830036979 | ELECTRODE/SURFACE SEPERATE PR |
| 00382830036962 | ELECTRODE/SURFACE TWISTED PAIR |
| 00382830036955 | ELC/DIG RING REUSABLE/18" LEAD |
| 00382830036887 | VQ AMP ISI-2 |
| 00382830036863 | VQ AMP ISI-4 |
| 00382830036757 | SONARA-TEK LAPTOP |
| 00382830036641 | NIC CSC64 SSU AMP W/CBL HOLDER |
| 00382830035927 | LRU/VS EA-4 AMPLIFIER SHLD/HSG-FIXED |
| 00382830035910 | ISOBOX 850VA SOTB FW 120V |
| 00382830035903 | LRU VikingQuest Base Unit F Part |
| 00382830035842 | LRU/SYNERGY HP TOWER USA-FIXED |
| 00382830034654 | Nicolet LED Goggles |
| 00382830034647 | Nicolet S403 Stimulus Probe |
| 00382830034630 | Nicolet Reflex Hammer |
| 00382830034623 | VikingQuest Auditory Stimulator |
| 00382830034579 | Endeavor CR Desktop PC |
| 00382830034500 | Viking Control Panel - German |
| 00382830034494 | Viking Control Panel - French |
| 00382830034456 | ELC/ERG-JET CONTACT LENS |
| 00382830034449 | TIP 3.5MM INFANT EARTIP (10PR) |
| 00382830034432 | TIP 4MM INFANT EARTIPS (10PR) |
| 00382830034425 | TIP 5MM INFANT EARTIPS (10PR) |
| 00382830034418 | ELC/DISP CENTR SNAP RND (10PK) |
| 00382830033893 | Viking EDX Control Panel |
| 00382830033879 | Synergy EDX Control Panel |
| 00382830033848 | EDX Desktop PC |
| 00382830033831 | EDX Desktop PC - Demo Sale |
| 00382830033824 | EDX Laptop PC |
| 00382830033817 | EDX Laptop PC - Demo Sale |
| 00382830033534 | UltraPro S100 Laptop PC |
| 00382830033411 | 24" SHIELDED LEADED WIRE FOR DISPOSABLE MONOPOLAR NEEDLES ELECTRODES |
| 00382830033381 | ELC/ALLERGAN NEEDLES 4 PCK |