FDA.reportPublic FDA data

NeurOptics

Primary DI
00850010118062
Brand
NeurOptics
Company
Neuroptics, Inc.
Model
NPi-300 Pupilometer System
Catalog number
NPi-300-SYS
Published
2021-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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
00850010118062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010118062008500101180628500101180620850010118062

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 Temperature-38 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966355802
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850010118079NeurOpticsNPi-200 SystemNPi-200 Kit2020-10-27
10850010118038NeurOpticsSG-200 SG-200 2020-10-27

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
00850010118079NeurOpticsNeuroptics, Inc.HLG2020-10-27
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