FDA.reportPublic FDA data

CATS

Primary DI
00860412001558
Brand
CATS
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
CATS-D
Catalog number
CATS-D
Device description
The CATS-D Tonometer prism is intended to be used with Goldmann type tonometers for the measurements of intraocular pressure of the human eye.
Published
2022-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HKYTonometer, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKYTonometer, ManualOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203850000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203850000CATS®-D Tonometer PrismCats Tonometer, LLC2021-06-14HKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860412001558PackageGS14In Commercial Distribution
00860412001541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860412001558008604120015588604120015580860412001558
00860412001541008604120015418604120015410860412001541

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer, manualAn ophthalmic, manually-operated, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force in direct contact with 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 device (known as a contact type, e.g., a Schioetz or Perkins tonometer) is used in the diagnosis of glaucoma and may be hand-held or used in conjunction with a slit lamp.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017535668
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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00850068519330SAM MedicalIO807IO8072026-05-07
B090MT630MorTan MT632026-02-17
B090MT2020MorTanMT202 2026-02-10
B090MT2021MorTanMT202 2026-02-10
B090XC2201450XO ConstrainXC2.20-1452026-02-03
B090XC2201451XO ConstrainXC2.20-1452026-02-03
00850068519231SAM Medical IO8422025-12-09
00850068519248SAM Medical IO847W-1P2025-12-09
00850068519255SAM Medical IO846W-1P2025-12-09
00850068519262SAM Medical IO845W-1P2025-12-09
10850068519238SAM Medical IO8422025-12-09
10850068519245SAM Medical IO847W-1P2025-12-09
10850068519252SAM Medical IO846W-1P2025-12-09
10850068519269SAM Medical IO845W-1P2025-12-09
B090P110900VentiV ScientificP11-090P11-0902025-11-24
B090P11090F0VentiV ScientificP11-090-FP11-090-F2025-11-24
B090P110901VentiV ScientificP11-090P11-0902025-11-24
B090P11090F1VentiV ScientificP11-090-FP11-090-F2025-11-24

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