FDA.reportPublic FDA data

Vapotherm

Primary DI
00841737103035
Brand
Vapotherm
Company
VAPOTHERM, INC.
Model
HiVNI-UKIT-ZA
Device description
Precision Flow HiVNI UKIT, South Africa
Published
2019-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAVHigh Flow/High Velocity Humidified Oxygen Delivery DeviceAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841737103035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841737103035008417371030358417371030350841737103035

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
040429050
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841737103219VapothermHVT20-UNIT2020-12-03
00841737105893VapothermHVT-UKIT-JP2025-11-19
00841737100089VapothermPF-DPC-HIGH2016-08-05
00841737100096VapothermPF-DPC-LOW2016-08-05
00841737100119VapothermPF-NODPC-LOW2016-08-05
00841737100737Vapotherm PF-WBA2018-03-20
00841737102038Vapotherm430005762022-05-31
00841737102397VapothermPF-DPC-High-BR2018-01-31
00841737102410VapothermPF-DPC-Low-BR2018-01-31
00841737102496VapothermPF-DPC-Low-WBA2018-02-15
00841737102502VapothermPF-DPC-High-WBA2018-02-15
00841737102984VapothermPF-ADPC-Low2019-05-20
00841737102991VapothermPF-ADPC-High2019-05-20
00841737103509VapothermPF-DPC-LOW-KR2020-07-14
00841737103516VapothermPF-DPC-HIGH-KR2020-07-14
00841737103653VapothermPF-NODPC-HIGH-BR2020-10-08
00841737103660VapothermPF-NODPC-LOW-BR2020-10-08
00841737103806VapothermPF-WBA-BR2020-10-08
00841737103820Vapotherm3003034-BR2020-10-15
00841737104469VapothermPF-ADPC-HIGH-IN2021-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012477873F&P Airvo 3FISHER & PAYKEL HEALTHCARE LIMITEDQAV2026-01-28
09420012474629Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2025-08-13
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
09420012466518F&P Airvo 3FISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-24
09420012466525F&P Airvo 3FISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-24
09420012466662Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-05
09420012470010Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-05
09420012470744F&P Airvo 3FISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-05
00841737105480VapothermVAPOTHERM, INC.QAV2022-03-03
00841737105497VapothermVAPOTHERM, INC.QAV2022-03-03
00841737105503VapothermVAPOTHERM, INC.QAV2022-03-03
00841737105367VapothermVAPOTHERM, INC.QAV2021-11-15
00841737105374VapothermVAPOTHERM, INC.QAV2021-11-15
00841737105381VapothermVAPOTHERM, INC.QAV2021-11-15
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