FDA.report

Vapotherm

Primary DI
00841737103646
Brand
Vapotherm
Company
VAPOTHERM, INC.
Model
HiVNI-UKIT-TR
Device description
Precision Flow Hi-VNI UKIT, Turkey
Published
2020-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device

Product Code Classifications

CodeDeviceSpecialtyClass
QAVHigh Flow/High Velocity Humidified Oxygen Delivery DeviceAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841737103646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841737103646008417371036468417371036460841737103646

GMDN Terms

TermDefinition
Electrical mains power cableAn insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
040429050
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
10841737102950VapothermUNICORN-ADULT2025-03-27
00841737102960VapothermUNICORN-PED2025-03-27
00841737105831VapothermHVT-BUYOUT2025-03-11
00841737105817VapothermHVT-UPGRADE-MODO2024-09-09
00841737105800VapothermHVT-UKIT-PH2024-08-26
00841737105787VapothermPF-OAM-MAS-BR2024-06-10
00841737105794VapothermPF-OAM-NEL-BR2024-06-10
00841737105763VapothermPF-OAM-MAS-UKIT-BR2024-06-03
00841737105770VapothermPF-OAM-NEL-UKIT-BR2024-06-03
00841737105725VapothermHPF-TA-22-BR2023-11-16
00841737105749VapothermHVT-BAT-BR2023-11-16
10841737105753VapothermHVT-DPC-BR2023-11-16
00841737105695VapothermHVT-VTU-OUS-BR2023-10-24
00841737105701VapothermHVT-UKIT-BR2023-10-24
00841737105718VapothermHVT20-UNIT-VTU-BR2023-10-24
00841737105664VapothermHVT20-UNIT-FLM2023-09-25
00841737105671VapothermHVT20-NEL-FLM2023-09-25
00841737105688VapothermHVT20-MAS-FLM2023-09-25
00841737105657VapothermPF-C-PLUS-FLM2023-05-30
00841737105633VapothermHVT-UKIT-CA2023-05-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
09420012477873F&P Airvo 3FISHER & PAYKEL HEALTHCARE LIMITEDQAV2026-01-28
09420012474421Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2025-08-13
00841737105831VapothermVAPOTHERM, INC.QAV2025-03-11
00841737105817VapothermVAPOTHERM, INC.QAV2024-09-09
00841737105800VapothermVAPOTHERM, INC.QAV2024-08-26
00841737105787VapothermVAPOTHERM, INC.QAV2024-06-10
00841737105794VapothermVAPOTHERM, INC.QAV2024-06-10
00841737105763VapothermVAPOTHERM, INC.QAV2024-06-03
00841737105770VapothermVAPOTHERM, INC.QAV2024-06-03
09420012479631Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2024-03-28
09420012470737Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-09-13
09420012466518Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-24
09420012466525Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-24
09420012466662Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-05
09420012470010Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-05
09420012470744Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-05
00841737105480VapothermVAPOTHERM, INC.QAV2022-03-03
00841737105497VapothermVAPOTHERM, INC.QAV2022-03-03
00841737105503VapothermVAPOTHERM, INC.QAV2022-03-03
00841737105336VapothermVAPOTHERM, INC.QAV2021-11-11
00841737105350VapothermVAPOTHERM, INC.QAV2021-11-11
00841737105008VapothermVAPOTHERM, INC.QAV2021-09-13
00841737104780VapothermVAPOTHERM, INC.QAV2021-07-15
00841737104797VapothermVAPOTHERM, INC.QAV2021-07-15
00841737104803VapothermVAPOTHERM, INC.QAV2021-07-15
00841737104810VapothermVAPOTHERM, INC.QAV2021-07-15
00841737104827VapothermVAPOTHERM, INC.QAV2021-07-15
00841737104834VapothermVAPOTHERM, INC.QAV2021-07-15
00841737104841VapothermVAPOTHERM, INC.QAV2021-07-15
00841737104858VapothermVAPOTHERM, INC.QAV2021-07-15