FDA.reportPublic FDA data

Vapotherm

Primary DI
10841737103056
Brand
Vapotherm
Company
VAPOTHERM, INC.
Model
PF-OAMDPC-LOW
Device description
Precision Flow Oxygen Assist Module, DPC LOW
Published
2019-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

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
10841737103056PackageGS13In Commercial Distribution
00841737103059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084173710305610841737103056
00841737103059008417371030598417371030590841737103059

GMDN Terms#

Term, Definition table
TermDefinition
High-flow heated respiratory humidifierA mains electricity (AC-powered) device designed to deliver high-flow (typically greater than 15 L/min) heated and humidified ambient air or air/oxygen to a patient as therapy for a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), bronchiectasis, xerostomia, and mucositis]. The gases are delivered to the patient's airway via the nose/mouth or a tracheostoma. It typically consists of a gas flow generator, a heating element, humidification chamber, and breathing tube(s). Healthcare providers prescribe the therapy, configure the breathing system, and adjust the patient settings; the device may be used in the hospital or home for spontaneously breathing patients.

Sterilization Methods#

Method table
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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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