FDA.reportPublic FDA data

VISUFIT 1000 Platform

Primary DI
04250668606663
Brand
VISUFIT 1000 Platform
Company
Carl Zeiss Vision GmbH
Model
000000-2194-446
Catalog number
000000-2194-446
Device description
N/A
Published
2021-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMFStand, instrument, ac-powered, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMFStand, Instrument, Ac-Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250668606663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250668606663042506686066634250668606663

GMDN Terms#

Term, Definition table
TermDefinition
Medical image management systemA computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0795 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(423)598-2680jahmal.cannon@zeiss.com

Regulatory Flags#

DUNS number
333928146
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
04250668607202VISUREF 600000000-2572-4242026-04-24
04250668607233ZEISS Mobile Centration000000-2750-321000000-2750-3212026-01-15
04250668606748VISU360000000-1011-377000000-1011-3772021-01-01
04250668606045VISUSCREEN 100 Compact000000-2522-536000000-2522-5362023-05-30
04250668606052VISUCORE 500 Refractor000000-2522-537000000-2522-5372023-05-30
04250668606618VISUCONSULT 500000000-2265-586000000-2265-5862021-01-01
04250668607172i.Terminal go000000-2408-309000000-2408-3092022-12-08
04250668606649i.Terminal mobile000000-2120-340000000-2120-3402021-01-01
04250668606687VISUFIT 1000000000-2351-293000000-2351-2932021-01-01
04250668606700i.Terminal 2 Station000000-2433-519000000-2433-5192021-01-01
04250668606625i.Profiler plus000000-1005-825000000-1005-8252021-01-01
04250668606694i.Terminal 2000000-1898-991000000-1898-9912021-01-01
04250668606755i.Profiler plus000000-2358-727000000-2358-7272021-01-01
04250668606670Avatar Generation000000-2351-295000000-2351-2952021-01-01
04250668606724VISUSCREEN 500000000-2087-230000000-2087-2302021-01-01
04250668606717i.Terminal 2000000-2408-310000000-2408-3102021-01-22
04250668606731VISUSCREEN 100000000-2069-910000000-2069-9102021-01-01
04250668606632ATLAS Review for i. Profiler plus000000-2360-422000000-2360-4222021-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436566190015TOPCONANTONI CARLES SAHMF2026-06-01
00850020301638RelianceHAAG-STREIT USA, INC.HMF2026-05-29
05907642694435Refraction UnitMDT SP Z O OHMF2025-08-08
00850020301607RelianceHAAG-STREIT USA, INC.HMF2025-08-04
00850020301614RelianceHAAG-STREIT USA, INC.HMF2025-08-04
00850020301621RelianceHAAG-STREIT USA, INC.HMF2025-08-04
05907642694459Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694466Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694473Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694480Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694497Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694510Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694534Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694541Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694565Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694589Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694596Refraction UnitMDT SP Z O OHMF2025-07-16
00850020301584RelianceHAAG-STREIT USA, INC.HMF2025-05-21
00850020301539RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301546RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301553RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301560RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301577RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00628308210015LombartINNOVA Medical Ophthalmics IncHMF2025-02-20
00628308210022S4 OptikINNOVA Medical Ophthalmics IncHMF2025-02-20
00628308210039MarcoINNOVA Medical Ophthalmics IncHMF2025-02-20
G699Q90630EyeCheq KioskEYECHEQ INC.HMF2024-10-17
05907642694442Refraction UnitMDT SP Z O OHMF2024-06-14
00850053428616IS-5500TOPCON HEALTHCARE INCHMF2024-05-28
00850053428517IS-6500TOPCON HEALTHCARE INCHMF2024-05-17