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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
Instrument chemical/thermal disinfectorAn electrically-powered unit intended to be used for both chemical and thermal disinfection of probes, surgical instruments, and/or endoscopes, and their accessories. It may include washing features and may have built-in features to circulate cleaning and disinfectant solutions through a device lumen; some types may also have built-in drying features. It is not intended for device sterilization.

Regulatory Flags#

DUNS number
600030209
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
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
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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