FDA.reportPublic FDA data

PDM Digital PD Meter

Primary DI
00812559010580
Brand
PDM Digital PD Meter
Company
REICHERT, INC.
Model
15020
Published
2025-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HLHPupillometer, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLHPupillometer, ManualOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812559010580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812559010580008125590105808125590105800812559010580

GMDN Terms#

Term, Definition table
TermDefinition
Pupillometer, electrically-poweredAn electrically-powered ophthalmic instrument intended to be used for measuring the width or diameter of the pupil. The patient will, e.g., view into this device and the operator will see the pupil and its shape.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
126650253
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812559010115Ocu-Film +2306512016-09-22
00812559012096Ocu-Film +2306532016-09-22
00812559012485" Ocu-Film® +"""2306532025-08-15
00812559012492"Ocu-Film® +"""2306512025-08-14
00812559011136UNISTAT® Bilirubinometer Specimen Cuvettes131021402025-08-12
00812559012454Ocu-Dot® Tonometer Probes - 100 Count163182025-08-12
00812559010238Ultramatic RX Master Phoropter11625B2025-08-12
00812559010269Ultramatic RX Master Phoropter11635B2025-08-12
00812559010290Illuminated Phoropter116362025-08-12
00812559010320Illuminated Phoropter116372025-08-12
00812559010559TF50 Trial Frame150102025-08-12
00812559010566TS75 Trial Lens150152025-08-12
00812559010900Tono-Vera® Tonometer Starter Kit, Rechargeable163062025-08-12
00812559011143UNISTAT® Bilirubinometer Specimen Cuvettes131021402025-08-12
00812559011419Quebec® Manual Darkfield Colony Counter133325002025-08-12
00812559011440Quebec® Digital Darkfield Colony Counter133327002025-08-12
00812559011495Reichert® Digital USG-Chek139400192025-08-12
00812559011518Clinical Refractometers Reichert® Digital Clinic-Chek139400212025-08-12
00812559011716Phoropter VRx162412025-08-12
00812559011730Phoropter VRx162422025-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628308210534LombartINNOVA Medical Ophthalmics IncHLH2026-03-31
00628308210541S4OptikINNOVA Medical Ophthalmics IncHLH2026-03-31
00628308210558PD-1INNOVA Medical Ophthalmics IncHLH2026-03-31
00860014277511Advancing EyecareLombart Brothers, Inc.HLH2025-07-28
06971922134064YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLH2022-04-21
06971922134026YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLH2022-03-21
06971922130080PupilometerChongqing Yeasn Science & Technology Co.,Ltd.HLH2020-10-22