FDA.reportPublic FDA data

NeurOptics

Primary DI
00850010118079
Brand
NeurOptics
Company
Neuroptics, Inc.
Model
NPi-200 System
Catalog number
NPi-200 Kit
Published
2020-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLGPupillometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLGPupillometer, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010118079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010118079008500101180798500101180790850010118079

GMDN Terms#

Term, Definition table
TermDefinition
PupillographA mains electricity (AC-powered) graphic recorder used for recording the response of the pupil to reflected light. It is used for ophthalmic diagnostic purposes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius75 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-250-9792info@neuroptics.com

Regulatory Flags#

DUNS number
966355802
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850010118024NeurOpticsNPi-300 Pupilometer SystemNPi-300-SYS2024-03-11
00850010118086NeurOpticsVIP-400 PupillometerVIP-4002024-03-11
00850010118093NeurOpticsVIP4-CHG Charging StationVIP4-CHG2024-03-11
00850010118109NeurOpticsPLR-4000 PupillometerPLR-40002024-03-11
00850010118116NeurOpticsVIP-400 Pupillometer SystemVIP-400-SYS2024-03-11
00850010118123NeurOpticsPLR-4000 Pupilometer SystemPLR-4000-SYS2024-03-11
00850010118000NeurOpticsNPi-300 PupilometerNPI-3002021-04-06
00850010118017NeurOpticsCHG-300 ChargerCHG-3002021-04-06
10850010118038NeurOpticsSG-200 SG-200 2020-10-27
00850010118062NeurOpticsNPi-300 Pupilometer SystemNPi-300-SYS2021-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03615020000397Digital C.R.PESSILOR INTERNATIONALHLG2026-04-09
04250668607233ZEISS Mobile CentrationCarl Zeiss Vision GmbHHLG2026-01-15
00857901006620RETeval™L K C TECHNOLOGIES, INC.HLG2025-07-01
00857901006637RETeval™L K C TECHNOLOGIES, INC.HLG2025-07-01
00850010118024NeurOpticsNeuroptics, Inc.HLG2024-03-11
00850010118086NeurOpticsNeuroptics, Inc.HLG2024-03-11
00850010118093NeurOpticsNeuroptics, Inc.HLG2024-03-11
00850010118109NeurOpticsNeuroptics, Inc.HLG2024-03-11
00850010118116NeurOpticsNeuroptics, Inc.HLG2024-03-11
00850010118123NeurOpticsNeuroptics, Inc.HLG2024-03-11
04049584022011Vissard 3D, linear polarizedOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHLG2022-12-01
04049584022158Vissard 3D, circular polarizedOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHLG2022-12-01
04049584025166Vissard RGOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHLG2022-12-01
03665023000627NL-2-DEMIDMEDHLG2022-06-10
00857901006392UTASL K C TECHNOLOGIES, INC.HLG2022-02-04
00857901006415UTASL K C TECHNOLOGIES, INC.HLG2022-02-04
00857901006439RETeval™L K C TECHNOLOGIES, INC.HLG2022-02-04
00857901006446RETeval™L K C TECHNOLOGIES, INC.HLG2022-02-04
00857901006453RETeval™L K C TECHNOLOGIES, INC.HLG2022-02-04
00857901006460RETeval™L K C TECHNOLOGIES, INC.HLG2022-02-04
00857901006477RETeval™L K C TECHNOLOGIES, INC.HLG2022-02-04
00850010118000NeurOpticsNeuroptics, Inc.HLG2021-04-06
00850010118017NeurOpticsNeuroptics, Inc.HLG2021-04-06
00850010118062NeurOpticsNeuroptics, Inc.HLG2021-04-06
10850010118038NeurOpticsNeuroptics, Inc.HLG2020-10-27
03665023000184NL-2IDMEDHLG2020-01-24
03665023000191NL-MUIDMEDHLG2020-01-24
03665023000429STA-W2IDMEDHLG2020-01-24
04987669100837PD MeterNIDEK CO.,LTD.HLG2018-04-20
00857901006019RETeval™L K C TECHNOLOGIES, INC.HLG2016-03-11