natus.comOLYMPIC COOL-CAP SYSTEM
Natus Medical Incorporated
Natus Medical Incorporated
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2023988 | 2023988 | Natus Medical Incorporated | 1 | N | 2026-01-01 | 6225 Nancy Ridge Dr SAN DIEGO CA US 92121 |
| 3018859 | 3018859 | NATUS MEDICAL INCORPORATED | 1 | Y | 2020-04-25 | 5900 FIRST AVE., SOUTH SEATTLE WA US 98108 |
| 3013242889 | 3013242889 | Natus Medical Incorporated | 1 | N | 2020-04-25 | 1183 Quarry Lane, Suite A Pleasanton CA US 94566 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00382830000727 | NATUS MEDICAL - OAE Jumbo Ear Tips - qty 20 | 1-800-303-0306 | Technical.Service@natus.com |
| 00382830008365 | Bio-logic - Disposable Snap Electrodes | 1-800-303-0306 | BLSC_Hearing_Support@natus.com |
| 00382830045247 | Echo-Screen III Pro - The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies. | 1-800-303-0306 | Technical.Service@natus.com |
| 00382830045278 | Echo-Screen III Pro - The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies. | 1-800-303-0306 | Technical.Service@natus.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 13254 | 1446370493 | P040025 | OLYMPIC COOL-CAP | MXM | 2006-12-20 |
| 212240 | 1611264281 | K971799 | PRECISION FLOW OSV II | JXG | 1998-02-06 |
| 13254 | 1181605975 | K971117 | WARMETTE | LHC | 1997-08-22 |
| 212240 | 1857378106 | K964923 | CODMAN LUMBAR DRAINAGE CATHETER KIT | JXG | 1997-06-25 |
| 212240 | 1770324098 | K962928 | COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) | GWM | 1996-12-20 |
| 212240 | 1016658295 | K960159 | CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS) | JXG | 1996-10-25 |
| 212240 | 1837910908 | K955832 | CORDIS VENTRICULAR ANTECHAMBER (VA) | JXG | 1996-03-25 |
| 212240 | 1274145477 | K954021 | EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) | JXG | 1995-10-24 |
| 13254 | 1682817518 | K952649 | WARM-SCALE | FRW | 1995-08-15 |
| 212240 | 1229967970 | K950315 | CORDIS CSF RESERVOIR | LKG | 1995-05-09 |
| 13254 | 1815545842 | K946229 | BALANCE MANAGER | KHX | 1995-08-04 |
| 212240 | 1096860316 | K944595 | CORDIS HORIZONTAL-VERICAL VALVE SYSTEM | JXG | 1995-10-19 |
| 13254 | 1579548870 | K935160 | MINIMUFFS | EWE | 1995-02-09 |
| 13254 | 1427871541 | K932881 | OLYMPIC WARM-LAMP | ILY | 1994-01-26 |
| 212240 | 1190308639 | K932273 | CORDIS TUNNELER | GYK | 1993-08-23 |
| 212240 | 2026442823 | K925810 | CORDIS POLYPROPYLENE BURR HOLE RESERVOIR | JXG | 1994-03-02 |
| 212240 | 1616666668 | K921936 | CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR | JXG | 1992-10-30 |
| 212240 | 1310138223 | K914735 | VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM | GWM | 1992-01-17 |
| 13254 | 1834097024 | K911955 | OLYMPIC WARMETTE | LDQ | 1991-07-19 |
| 212240 | 1299447256 | K911433 | RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE | JXG | 1991-09-16 |
| 212240 | 1029984437 | K910938 | CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) | JXG | 1991-08-16 |
| 212240 | 1039652435 | K895868 | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE | GYK | 1989-10-31 |
| 212240 | 1754520275 | K861377 | STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES | JXG | 1986-06-19 |
| 212240 | 1413948315 | K811288 | SPETZLER LUMBAR-PERITONEAL SYSTEM | JXG | 1981-06-26 |
| 212240 | 1601327080 | K802586 | AMERICAN HEYER-SCHULTE LOW PROFILE VALVE | JXG | 1980-12-18 |
| 212240 | 1937071511 | K771529 | PERITONEAL INTRODUCER & SHEATH | GYK | 1977-08-16 |
| 210659 | 1799332854 | K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable | HKI | 2018-09-07 |
| 13254 | 1095558818 | K182178 | neoBLUE blanket LED Phototherapy System | LBI | 2018-12-13 |
| 212240 | 1809559173 | K162437 | Codman EDS3 CSF External Drainage System | JXG | 2016-10-28 |
| 212240 | 1447822492 | K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems | JXG | 2016-09-22 |
| 13254 | 1359388888 | K160745 | neoBLUE compact LED Phototherapy System | LBI | 2016-12-12 |
| 13254 | 2014137325 | K160305 | neoBLUE® LED Phototherapy System | LBI | 2016-05-27 |
| 212240 | 1062647528 | K153041 | Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling | JXG | 2016-03-14 |
| 212240 | 1233753583 | K152897 | Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory | JXG | 2016-03-04 |
| 212240 | 1118846402 | K152481 | DURAFORM Dural Graft Implant | GXQ | 2015-10-30 |
| 13254 | 1204011015 | K152301 | Background Pattern Classification [BPc(TM)] | OMA | 2016-06-03 |
| 13254 | 1982967445 | K141446 | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, | GWJ | 2014-08-22 |
| 212240 | 1362815679 | K133754 | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER | GWM | 2014-03-06 |
| 13254 | 1489322299 | K123079 | OLYMPIC BRAINZ MONITOR | OMA | 2013-05-08 |
| 13254 | 2071325430 | K122496 | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | EWO | 2012-11-01 |
| 212240 | 1931539437 | K121573 | INTEGRA CAMINO ICP MONITOR | GWM | 2012-09-10 |
| 13254 | 1719254077 | K121512 | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | EWO | 2012-07-26 |
| 212240 | 1469956739 | K121159 | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER | GWM | 2012-07-20 |
| 13254 | 1000163453 | K112247 | A BAER WITH ABAER I/O FUNCTION | EWO | 2012-04-02 |
| 13254 | 1004998033 | K111618 | AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION | EWO | 2011-12-28 |
| 13254 | 1450224289 | K103589 | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM | LBI | 2011-05-13 |
| 212240 | 1991843813 | K102875 | CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C | GWM | 2010-12-20 |
| 210659 | 1134738104 | K102859 | RETCAM 3 OPTHALMIC IMAGING SYSTEM | HKI | 2011-04-20 |
| 212240 | 1691581351 | K101381 | HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS | JXG | 2011-07-07 |
| 13254 | 1860638933 | K093949 | OLYMPIC BRAINZ MONITOR MODEL OBM70001 | OMA | 2010-06-16 |
| 210659 | 1158771191 | K090326 | RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS | HKI | 2009-11-25 |
| 13254 | 1146649019 | K083371 | NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) | GWF | 2009-12-08 |
| 13254 | 1431791737 | K073665 | ALGO 5 NEWBORN HEARING SCREENER | GWJ | 2008-01-25 |
| 13254 | 1941263045 | K073626 | BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM | GWJ | 2008-02-05 |
| 212240 | 1216605962 | K061568 | CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 | JXG | 2006-09-29 |
| 13254 | 1031918136 | K051869 | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM | LBI | 2005-10-07 |
| 212240 | 1817538642 | K033698 | CONTOUR-FLEX VALVE AND SHUNT SYSTEM | JXG | 2003-12-17 |
| 13254 | 1617468374 | K031352 | BIO-LOGIC INSERT EARPHONES | EWO | 2003-07-16 |
| 13254 | 1021162120 | K031149 | OLYMPIC CFM 6000 | OMA | 2003-05-14 |
| 13254 | 1311144912 | K031009 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM | GWJ | 2003-04-28 |
| 13254 | 1860470555 | K030823 | ALGO 3I NEWBORN HEARING SCREENER | GWJ | 2003-04-09 |
| 212240 | 1234615450 | K022712 | HAND DRILL, MODEL 11-9901-7 | HBG | 2002-11-12 |
| 13254 | 1768997000 | K022196 | NATUS BLUE LIGHT PHOTOTHERAPY UNIT | LBI | 2002-09-19 |
| 13254 | 1463397761 | K013977 | ECHO-SCREEN T, TA, TD, TDA, TC | GWJ | 2002-06-14 |
| 13254 | 1702071051 | K012384 | EAR MUFFINS | HCC | 2001-10-15 |
| 210659 | 1863337869 | K001275 | RETCAM II | HKI | 2000-07-13 |
| 13254 | 1127589257 | ||||
| 13254 | 1300336019 | ||||
| 13254 | 1693799991 | ||||
| 13254 | 1767668219 | ||||
| 13254 | 1810265326 | ||||
| 13254 | 1939746991 | ||||
| 13254 | 1956853969 | ||||
| 13254 | 2042121092 | ||||
| 212240 | 1192998598 | ||||
| 212240 | 1774890116 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JXG | 20 | 2016-10-28 |
| LBI | 6 | 2018-12-13 |
| GWJ | 6 | 2014-08-22 |
| GWM | 6 | 2014-03-06 |
| EWO | 5 | 2012-11-01 |
| HKI | 4 | 2018-09-07 |
| OMA | 4 | 2016-06-03 |
| GYK | 3 | 1993-08-23 |
| GXQ | 1 | 2015-10-30 |
| GWF | 1 | 2009-12-08 |
| MXM | 1 | 2006-12-20 |
| HBG | 1 | 2002-11-12 |
| HCC | 1 | 2001-10-15 |
| LHC | 1 | 1997-08-22 |
| FRW | 1 | 1995-08-15 |
| KHX | 1 | 1995-08-04 |
| LKG | 1 | 1995-05-09 |
| EWE | 1 | 1995-02-09 |
| ILY | 1 | 1994-01-26 |
| LDQ | 1 | 1991-07-19 |
PMA#
OLYMPIC COOL CAP
Natus Medical Incorporated
OLYMPIC COOL-CAP SYSTEM
Natus Medical Incorporated
OLYMPIC COOL-CAP SYSTEM
Natus Medical Incorporated
OLYMPIC COOL-CAP SYSTEM
Natus Medical Incorporated
OLYMPIC COOL-CAP SYSTEM
Natus Medical Incorporated
OLYMPIC COOL-CAP SYSTEM
Natus Medical Incorporated
OLYMPIC COOL-CAP SYSTEM
Natus Medical Incorporated
OLYMPIC COOL-CAP SYSTEM
Natus Medical Incorporated
COOL CAP SYSTEM
Natus Medical Incorporated
OLYMPIC COOL-CAP
Natus Medical Incorporated
PMN#
NeoBLUE Blanket LED Phototherapy System
Natus Medical Incorporated
RetCam 3 ; RetCam Shuttle ; RetCam Portable
Natus Medical Incorporated
NeoBLUE Compact LED Phototherapy System
NATUS MEDICAL INCORPORATED
NeoBLUE® LED Phototherapy System
Natus Medical Incorporated
Natus Quantum
NATUS MEDICAL INCORPORATED
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
NATUS MEDICAL INCORPORATED
A BAER WITH ABAER I/O FUNCTION
NATUS MEDICAL INCORPORATED
AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
NATUS MEDICAL INCORPORATED
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
NATUS MEDICAL INCORPORATED
NEUROLINK IP MODEL: PK1117
NATUS MEDICAL INCORPORATED
GUDID#
Bio-logic - Disposable Snap Electrodes
2016-12-30
Echo-Screen III Pro - The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies.
2020-02-20
Echo-Screen III Pro - The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies.
2020-02-20
Echo-Screen III Pro - The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies.
2020-02-20
Echo-Screen III Pro - The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies.
2020-02-20
Echo-Screen III Pro - The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies.
2020-02-20
Echo-Screen III Pro - The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies.
2020-02-20
NATUS MEDICAL - OAE Jumbo Ear Tips - qty 20
2016-10-26
Bio-logic - OAE Pediatric Foam Ear Tip
2016-12-30
Bio-logic - OAE Adult Foam Tip
2017-03-31
Bio-logic - OAE Tree Tip
2017-03-31
Bio-logic - OAE Preemie TreeTip
2017-03-31
Bio-logic - OAE Jumbo Foam Tip
2017-03-31
Bio-logic - OAE Pediatric Foam Ear Tip
2016-12-30
Bio-logic - OAE Adult Foam Tip
2017-03-31
Bio-logic - OAE TreeTip
2017-03-31
Bio-logic - OAE Preemie TreeTip
2017-03-31
Bio-logic - OAE 6mm Blue Ear Tip
2016-12-30
Bio-logic - OAE 6mm Blue Ear Tip
2016-12-30
Natus - Reusable Silver Disc Electrod silicone leads
2017-05-09
Natus - Resuable Silver-Chloride Disc Electrode silicon leads
2017-05-09
Natus - Reusable Silver Disc Electrode teflon lead
2017-05-09
Natus - Reusable Gold Disc electrode teflon leads
2017-05-09
Bio-logic - Halo Ear Muffins with Tab Electrodes
2017-03-31
Bio-logic - Infant Tip Adapter for use with 580-SINSER Insert Earphones
2017-04-03
Bio-logic - Halo EarMuffin Adapter Tube for use with 580-SINSER insert earphone
2017-04-13
Bio-logic - The ABaer Hearing Screening System performs automated objective hearing screening utilizing auditory brainstem responses (ABR) and/or otoacoustic emissions (OAE).
2016-12-22
Natus - "Reusable Molded Silver EEG 10mm Disc Electrodes with 48"" (1.2m) PVC lead wires"
2017-05-09
Natus - Resuable Jumper Electrode cable, red
2017-05-09
Natus - Reusable Jumper Electrode cable, black
2017-05-09
AuDX Otoacoutic Emissions Measurement System wirh AuDX I/O Function - The AuDX I/O Function is a Windows based softwsre application for use with the AuDX otoacoustic Emissions Measurement System. The AuDX I/O software enables the AuDX device user to perform DPOAE testing at different test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level presented versus measured DPOAE level provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE responses.
2017-09-11
AuDX Pro Otoacoustic Emissions Measurement System - The AuDX Pro Otoacoustic Emissions Measurement System is a handheld battery operated device that performs otoacoustic emissions tests. Connection to the patient's ear is via the Bio-logic ear probe. Using a combination of hardware and software, the system produces a controlled acoustic signal in the ear canal and measures the resultiing evoked emissions that are generated by the outer hair cells of the inner ear associated with normal cochlear function. The stimuli are presented via miniature receivers and the acoustic response in the external ear canal is recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved.
2017-09-11
Scout Sport Otoacoustic Emissions Measurement System - The Scout Sport Otoacoustix Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE input/output (I/O) tests.
2017-09-11
Bio-Logic Algo Supplies - Bio-Logic Algo Supplies kit containing Flexicouplers and JellyTabs intended to be used with Natus hearing screeners.
2018-12-13
Olympic Bili-Bassinet - Disposable Mattress Covers, mattress with separate bolster for Olympic Bili-Bassinet
2017-05-19
Olympic Bili-Bassinet - Disposable Mattress Covers, one-piece mattress for Bili-Bassinet
2017-05-19
Olympic Bili-Lite Pad - Disposable Covers for Bili-Lite Pad
2017-05-19
neoBLUE - Disposable mattress cover for the neoBLUE Cozy LED Phototherapy System
2016-12-29
neoBLUE LED Phototherapy System - The neoBLUE LED Phototherapy System is a floor-standing, mobile phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia.The neoBLUE® Phototherapy System consists of two products – the neoBLUE LED Phototherapy light source (light) and the neoBLUE LED Phototherapy roll stand.
2017-04-18
neoBLUE - neoBLUE blanket Large Pad Kit
2018-12-17