FDA.reportPublic FDA data

TIVA10-1V-HS-MD

Primary DI
07290110640880
Brand
TIVA10-1V-HS-MD
Company
TUTTNAUER ISRAEL LTD.
Model
TIVA10-1V-HS-MD
Catalog number
TIVA10-1V-HS-MD
Device description
High Level Disinfector
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LDSDevice, Pasteurization, Hot Water

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDSDevice, Pasteurization, Hot WaterGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110640880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110640880072901106408807290110640880

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument washer/disinfector (chemical/thermal)An electrically-powered unit intended to both wash and disinfect a range of surgical instruments, and typically also ancillary utensils (e.g., containers), using both heat and a disinfectant solution; it is not dedicated to washing/disinfecting a specific device type. The device includes an internal chamber containing baskets/racks onto which the devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals typically in a reprocessing suite.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600030209
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
07290110640606TIVA2 TDTIVA2 TDTIVA2 TD2023-06-20
07290110640613TIVA2-H TDTIVA2-H TDTIVA2-H TD2023-06-20
07290110640897TIVA10-2V-HS-MDTIVA10-2V-HS-MDTIVA10-2V-HS-MD2023-06-20
07290110642013TIVA8-MDTIVA8-MDTIVA8-MD2023-06-20
072901106407983870HSG3870HSG-WS-230-D2022-12-22
072901106422353870HSG3870HSG-230-D2022-12-22
05060474070003Model T-ClassicModel T-Classic2022-11-22
07290110640644T-Edge 10 T-Edge 10 AMS10-120-W-T2020-11-16
07290110640651T-Edge 10 T-Edge 10 AMS10-120-T 2020-11-16
07290110640729T-Edge 11 AMS11-230-W-T AMS11-230-W-T2021-06-07
07290110640736T-Edge 11 AMS11-230-T AMS11-230-T2021-06-07
07290110640705 T-Edge 11 AMS11-120-TAMS11-120-T2021-03-11
07290110640712T-Edge 11 AMS11-120-W-TAMS11-120-W-T2021-03-11
07290110640446T-Edge 10 T-Edge 10 AMS10-230-W-T2019-12-01
07290110640439T-Edge 10T-Edge 10AMS10-230-T2019-11-27
072901106407435596-1R-L-USA5596-1R Model5596-1R-L-USA2021-05-09
072901106407505596-1R-R-USA5596-1R Model5596-1R-R-USA2021-05-09
07290110640668Model 44724472-2V4472-2V2020-12-08
072901106406372540MKA2540MKATTA2540-1R23MKA2020-07-21
07290110640453Model 5596-1VModel 5596-1V5596-1V-L-USA2020-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640397420390HIP Ultra Cleaning SolutionDent4You AGLDS2026-05-06
07640397420406HIP Cleaning SolutionDent4You AGLDS2026-05-06
07640397422332HIP Cleaning SolutionDent4You AGLDS2026-02-11
07640397422189HYDRIM 112W G4+ Instrument WasherDent4You AGLDS2026-02-11
17640397422339HIP Cleaning SolutionDent4You AGLDS2026-02-11
07640397422349HYDRIM 112W G4+ Instrument WasherDent4You AGLDS2026-02-11
07640397422356HYDRIM 112W G4+ Instrument WasherDent4You AGLDS2026-02-11
E308210050010Talos+ RIW-100TTW & H STERILIZATION SRLLDS2025-12-23
E308210060010Talos+ RIW-100UCW & H STERILIZATION SRLLDS2025-12-23
07640397421885HYDRIM C61W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421892HYDRIM C61W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421908HYDRIM C61W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421915HYDRIM L110W Instrument WasherDent4You AGLDS2025-01-15
07640397421922HYDRIM L110W Instrument WasherDent4You AGLDS2025-01-15
07640397421939HYDRIM L110W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421946HYDRIM L110W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421953HYDRIM L110W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421960HYDRIM L110W G4 Instrument WasherDent4You AGLDS2025-01-15
07290110640606TIVA2 TDTUTTNAUER ISRAEL LTD.LDS2023-06-20
07290110640613TIVA2-H TDTUTTNAUER ISRAEL LTD.LDS2023-06-20
07290110640897TIVA10-2V-HS-MDTUTTNAUER ISRAEL LTD.LDS2023-06-20
07290110642013TIVA8-MDTUTTNAUER ISRAEL LTD.LDS2023-06-20
00852494007078CenorinCENORIN, L.L.C.LDS2021-07-15
00852494007085CenorinCENORIN, L.L.C.LDS2021-07-15
07540196001076HIPScican LtdLDS2020-11-09
07540196001083HIP UltraScican LtdLDS2020-11-09
07540196001090HIPScican LtdLDS2020-11-09
07540196000680HYDRIM L110W G4 Instrument WasherScican LtdLDS2018-09-07
07540196000994HYDRIM L110W G4 Instrument WasherScican LtdLDS2018-01-17
07540196001007HYDRIM L110W Instrument WasherScican LtdLDS2018-01-17