Natus 101091
GUDID 00382830001489
Reusable Molded Silver EEG 10mm Disc Electrodes with 48" (1.2m) PVC lead wires
NATUS MEDICAL INCORPORATED
Evoked-potential audiometer| Primary Device ID | 00382830001489 |
| NIH Device Record Key | db470ebc-9cc3-4795-bffa-71360b481f9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Natus |
| Version Model Number | Silver Disc Electrode |
| Catalog Number | 101091 |
| Company DUNS | 962519208 |
| Company Name | NATUS MEDICAL INCORPORATED |
| Device Count | 5 |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382830001489 [Primary] |
| GS1 | 00382830054546 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030823
FDA Product Code
| EWO | Audiometer |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-09 |
On-Brand Devices [Natus ]
| 00382830054430 | Infant Ear Tip, Transparent Blue, Size 5.5 mm, Qty 50 |
| 00382830054393 | Ear Probe Tip, Blue, Qty 10 |
| 00382830054386 | Adult Ear Tip, Yellow Foan, Size 17 mm, Qty 50 |
| 00382830054379 | Child/Adult Ear Tip, Gray, size 11 mm, Qty 50 |
| 00382830054362 | Child/Adult Ear Tip, Red-Brown, size 10 mm, Qty 50 |
| 00382830054355 | Child/Adult Ear Tip, Transparent Pink, size 9 mm, Qty 50 |
| 00382830054348 | Child/Adult Ear Tip, Blue, size 8 mm, Qty 50 |
| 00382830054331 | Child/Adult Ear Tip, White, size 7 mm, Qty 50 |
| 00382830054270 | Child/Adult Ear Tip, Transparent, size 6 mm, Qty 50 |
| 00382830054263 | Infant Ear Tip, Yellow, Size Tree, Qty 50 |
| 00382830054256 | Infant Ear Tip, Green, Size Mushroom, Qty 50 |
| 00382830054249 | Infant Ear Tip, Green, Size 5mm, Qty 50 |
| 00382830054201 | Infant Ear Tip, Red-Brown, Size 4.5 mm, Qty 50 |
| 00382830054188 | Infant Ear Tip, Blue, Size 4 mm, Qty 50 |
| 00382830054171 | Adult Ear Tip, 13.7 mm, yellow foam |
| 00382830054164 | Child/Adult Ear Tip, 12 mm, mustard |
| 00382830053679 | Tiptrode Electrode Cable, red/blue |
| 00382830053648 | Reusable Gold Disc electrode tangle free |
| 00382830047104 | Reusable Gold Ear Clip electrode, Adult, 10 mm |
| 00382830047098 | Reusable Gold Ear Clip electrode, Pediatric, 6 mm |
| 00382830047081 | Reusable Silver-Chloride Ear Clip electrode, Adult, 10 mm |
| 00382830047067 | Reusable Silver Ear Clip electrode, Adult, 10 mm |
| 00382830047050 | Reusable Silver Ear Clip electrode, Pediatric, 6 mm |
| 00382830044486 | Infant/Child Ear Tip Foam, Size 9.5 mm, Qty 50 |
| 00382830044479 | Compressible Foam Ear Tip, 7 mm, flesh |
| 00382830001526 | Reusable Jumper Electrode cable, black |
| 00382830001519 | Resuable Jumper Electrode cable, red |
| 00382830001489 | Reusable Molded Silver EEG 10mm Disc Electrodes with 48" (1.2m) PVC lead wires |
| 00382830000918 | Reusable Gold Disc electrode teflon leads |
| 00382830000901 | Reusable Silver Disc Electrode teflon lead |
| 00382830000888 | Resuable Silver-Chloride Disc Electrode silicon leads |
| 00382830000871 | Reusable Silver Disc Electrod silicone leads |
| 10382830062333 | CRANIAL ACCESS KIT |
| 10382830062326 | CRANIAL ACCESS KIT |
| 10382830062319 | CRANIAL ACCESS KIT |
| 10382830062302 | CRANIAL ACCESS KIT |
| 10382830062296 | CRANIAL ACCESS KIT |
| 10382830062289 | CRANIAL ACCESS KIT |
| 00382830062190 | Intracranial Pressure and Temperature Monitor |
| 00382830059817 | Monitor Adapter Cable, ICP, GE Marquett With TramRak |
| 00382830059800 | Monitor Adaptor Cable, ICP, Philips MMS (TRANSPORT) |
| 00382830059794 | Monitor Adapter Cable, ICP, MDE |
| 00382830059787 | Monitor Adapter Cable, ICP, MARQUETTE TRAM 400 SERIES |
| 00382830059770 | Monitor Adapter Cable, ICP, 10S ROCHE |
| 00382830059763 | Monitor Adapter Cable, ICP, HP, MERLIN SERIES |
| 00382830059756 | Monitor Adapter Cable, ICP, 5 PIN NIHON-KOHDEN |
| 00382830059749 | Monitor Adapter Cable, ICP, 10S BURDICK M200 M500 SERIES |
| 00382830059732 | Monitor Adapter Cable, ICP, SPACELABS |
| 00382830059725 | Monitor Adapter Cable, ICP, 5 PIN SPACELABS |
| 00382830059718 | Monitor Adapter Cable, ICP, MARQUETTE |
Trademark Results [Natus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NATUS 87624187 5453399 Live/Registered |
Natus Medical Incorporated 2017-09-27 |
 NATUS 86540434 4812806 Live/Registered |
Natus Medical Incorporated 2015-02-19 |
 NATUS 85893616 not registered Dead/Abandoned |
Lestat, Ofel 2013-04-03 |
 NATUS 85653367 not registered Dead/Abandoned |
RagTrade Industries, LLC 2012-06-15 |
 NATUS 85437060 4153501 Live/Registered |
Natus Medical Incorporated 2011-09-30 |
 NATUS 74073532 1637520 Live/Registered |
Natus Medical Inc. 1990-06-28 |
 NATUS 73834858 1635226 Dead/Cancelled |
NATUS CORPORATION 1989-10-30 |
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