FDA.reportPublic FDA data

Keeler Disposable Tonomate - BX 100

Primary DI
05055272718042
Brand
Keeler Disposable Tonomate - BX 100
Company
KEELER LIMITED
Model
2414-P-7039
Published
2016-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055272718042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055272718042050552727180425055272718042

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
210164398
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
true
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
Primary DIBrandModelCatalogPublished
05055272707503ADAPTOR FOR F SIZE CO2 CYLINDER2508-P-70162025-03-26
05055272707527ADAPTOR FOR F SIZE N2O CYLINDER2508-P-70182025-03-26
05055272721424DORC CRYOSTAR ADAPTOR2509-P-80362025-03-26
05055272721431ERBE ERBOKRYO ADAPTOR2509-P-80372025-03-26
05055272719674532nm LIO1205-P-21302021-07-20
05055272720328514/810nm LIO1205-P-21702021-07-20
05055272720380577nm LIO1205-P-21802021-07-20
050552727199263.6V PROFESSIONAL OPHTH IN CASE1128-P-1014-5002020-02-27
050552727199333.6V SPECIALIST OPHTH IN CASE1132-P-1157-5002020-02-27
050552727199403.6V PROFESSIONAL STREAK RETINOSCOPE IN CASE1302-P-1011-5002020-02-27
050552727199573.6V PROFESSIONAL STREAK LED RETINOSCOPE IN CASE1302-P-1014-5002020-02-27
05055272719964US PROFESSIONAL LED STUDENT KIT-SLIM1427-P-1100-5002020-02-27
05055272719971US PROFESSIONAL COMPLETE LED STUDENT SET1427-P-1127-5002020-02-27
050552727199883.6V PRACTITIONER/ FIBRE-OPTIC DIAGNOSTIC SET1729-P-1024-5002020-02-27
05055272719995SLIMLINE RECHARGEABLE HANDLE & BATTERY1911-P-1201-5002020-02-27
05055272720007RECHARGEABLE HANDLE & REFRACTION STAND ADAPTOR1911-P-1244-5002020-02-27
05055272720038US LED SPECIALIST/ RETINOSCOPE STUDENT SET1427-P-1130-5002020-02-27
05055272701204API 2/2 IN CARTON1204-P-30362016-08-26
05055272700641Pocket Set 2.8v1102-P-10412016-08-16
050552727007643.6V PROFESSIONAL OPHTH HEAD ONLY1128-P-10042016-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00812559012492Ocu-Film® +"REICHERT, INC.HKY2025-08-14
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
00887482112366Symmetry Surgical®SYMMETRY SURGICAL 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
03664188000114LuneauLUNEAU TECHNOLOGY OPERATIONSHKY2023-06-08
00860000603805Automated Ophthalmics Softips AUTOMATED OPHTHALMICS, INC.HKY2022-11-17
00860412001558CATSZIEN MEDICAL TECHNOLOGIES, INC.HKY2022-10-12
06430033851456iCare HOME2ICARE FINLAND OYHKY2022-02-08
06945087580004MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HKY2021-05-19
06945087580011MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.HKY2021-05-19
08056098470425S4 OPTIKCOSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRLHKY2020-12-14
08056098470517S4 OPTIKCOSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRLHKY2020-12-14
26973211070415Applanation TonometerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHKY2020-07-02
26973211070453Applanation TonometerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHKY2020-07-02