FDA.reportPublic FDA data

Accupen

Primary DI
00897826002000
Brand
Accupen
Company
ACCUTOME, INC.
Model
24-3000
Catalog number
24-3000
Published
2016-09-13
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
HKYTonometer, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKYTonometer, ManualOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00897826002000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00897826002000008978260020008978260020000897826002000

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer, battery-operatedAn ophthalmic, battery-powered, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This hand-held device (known as a contact type, e.g., a Perkins tonometer) is often used for, e.g., the examination of postoperative, bedridden and paediatric patients.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
048792816
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00897826002086AccuTip CoverAX9950AX99502016-09-13
00897826002093AccuTip Cover AX11932AX119322016-09-13
00897826002109AccuTip Cover AX11526AX115262016-09-13
00897826002116AccuTip Cover AX11286AX112862016-09-13
00897826002017Pachpen24-510024-51002016-09-13
00897826002024A-scan Plus Connect24-440024-44002016-09-13
00897826002031B-scan Plus24-610024-61002016-09-13
00897826002055Accupach VI24-620024-62002016-09-13
00897826002062B-scan Pro24-640024-64002016-09-13
008978260020794Sight24-800024-80002016-09-13
008978260021474Sight: Software Package2.06.02-U2016-09-21
00897826002178B-scan Plus: Software Package4.07.02-U2016-09-21
00897826002185A-scan Plus Connect: Software Package7.00.02-U2016-09-21
00897826002192B-scan Plus Software Package: Veterinary Version1.03.03-U2016-09-23
00897826002208B-scan Pro Software Package: Veterinary Version4.07.02-U2016-09-23
00897826002222B-scan Plus- VET24-6100-V24-6100-V2016-10-14
00897826002239B-scan Pro- VET24-6400-V24-6400-V2016-10-14
00897826002253Pachpen- VET24-5100-V24-5100-V2016-10-14
00897826002048UBM Plus24-630024-63002016-09-13
00897826002161UBM Plus: Software Package4.07.02-U2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841668146477KATENAKATENA PRODUCTS, INC.HKY2026-03-02
10841668146474KATENAKATENA PRODUCTS, INC.HKY2026-03-02
06430033851920iCare ST500ICARE FINLAND OYHKY2025-12-05
06430033852415iCare IC100ICARE FINLAND OYHKY2025-12-04
06430033852514iCare IC200ICARE FINLAND OYHKY2025-12-04
00812559012485" Ocu-Film® +"""REICHERT, INC.HKY2025-08-15
00812559012492"Ocu-Film® +"""REICHERT, INC.HKY2025-08-14
00812559012454Ocu-Dot® Tonometer Probes - 100 CountREICHERT, INC.HKY2025-08-12
00812559010900Tono-Vera® Tonometer Starter Kit, RechargeableREICHERT, INC.HKY2025-08-12
00812559011945Tono-Vera® Tonometer Starter Kit, AA BatteryREICHERT, INC.HKY2025-08-12
00812559012324Ocu-Dot® Tonometer Probes - 100 CountREICHERT, INC.HKY2025-08-12
00757770407309Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770408856Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770417629Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770420803Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770426867Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
06430033851784ST500 SmartCradleICARE FINLAND OYHKY2024-11-07
06430033851791ST500 AdapterICARE FINLAND OYHKY2024-11-07
06430033851807ST500 RemoteICARE FINLAND OYHKY2024-11-07
06430033851883iCare ST500ICARE FINLAND OYHKY2024-11-07
00887482112366Symmetry Allen-SchiotzASPEN SURGICAL PRODUCTS, INC.HKY2024-08-20
06430033851098iCare PATIENT2ICARE FINLAND OYHKY2024-04-23
06430033851104iCare PATIENT2ICARE FINLAND OYHKY2024-04-23
06430033851463iCare IC200ICARE FINLAND OYHKY2023-06-20
08800019600411Applanation Tonometer HT-5000Huvitz Co., Ltd.HKY2023-06-12
04560323648564TAKAGITAKAGI SEIKO CO.,LTD.HKY2023-06-09
03664188000138LuneauLUNEAU TECHNOLOGY OPERATIONSHKY2023-06-08
03664188000114LuneauLUNEAU TECHNOLOGY OPERATIONSHKY2023-06-08
00860000603805Automated Ophthalmics Softips AUTOMATED OPHTHALMICS, INC.HKY2022-11-17
00860412001541CATSZIEN MEDICAL TECHNOLOGIES, INC.HKY2022-10-12