FDA.reportPublic FDA data

TIANNUO / TNMED

Primary DI
06945033902249
Brand
TIANNUO / TNMED
Company
Lianyungang Tiannuo Optical Instrument Co., Ltd.
Model
TN-30R
Published
2017-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKYTonometer, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKYTonometer, ManualOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142263000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142263000Applanation TonometerShanghai Mediworks Precision Instruments Co. , Ltd.2016-04-15HKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945033902249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945033902249069450339022496945033902249

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer, line-poweredAn ophthalmic, line-powered, measuring instrument used 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). It typically has no contact with the eye and can use various techniques, e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air; the applanation tonometer records the indentation pressure in thousands of a second. It is used for the diagnosis of glaucoma, designed for table top use and may provide the data on a screen and/or a print-out.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420658999
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945033901808TIANNUO / TNMEDTN-5J2016-09-24
06945033901815TIANNUO / TNMEDTN-5F2016-09-24
06945033901822TIANNUO / TNMEDTN-5F12016-09-24
06945033901839TIANNUO / TNMEDTN-5S2016-09-24
06945033901846TIANNUO / TNMEDTN-S2802016-09-24
06945033901853TIANNUO / TNMEDTN-S280S2016-09-24
06945033901860TIANNUO / TNMEDTN-S3502016-09-24
06945033901877TIANNUO / TNMEDTN-S350S2016-09-24
06945033901884TIANNUO / TNMEDTN-S3902016-09-24
06945033902256TIANNUO / TNMEDTN-S3602018-06-12
06945033902263TIANNUO / TNMEDTN-S360C2018-06-12
06945033902270TIANNUO / TNMEDTN-S2602019-01-10
06945033902072TIANNUO / TNMEDTN-102A2018-09-24
06945033902089TIANNUO / TNMEDTN-5002018-09-24
06945033902096TIANNUO / TNMEDTN-510C2018-09-24
06945033902102TIANNUO / TNMEDTN-7002018-09-24
06945033902119TIANNUO / TNMEDTN-8202018-09-24
06945033902126TIANNUO / TNMEDTN-10102018-09-24
06945033902133TIANNUO / TNMEDTN-10202018-09-24
06945033902140TIANNUO / TNMEDTN-20002018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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