FDA.reportPublic FDA data

Vapotherm

Primary DI
00841737105725
Brand
Vapotherm
Company
VAPOTHERM, INC.
Model
HPF-TA-22-BR
Device description
HPF-TA-22-BR
Published
2023-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072845000PRECISION FLOWVapotherm, Inc.2008-07-17BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841737105722PackageGS150In Commercial Distribution
00841737105725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084173710572210841737105722
00841737105725008417371057258417371057250841737105725

GMDN Terms#

Term, Definition table
TermDefinition
Professional high-flow respiratory unit, humidifyingAn electrically-powered device designed to deliver high-flow (exceeding peak inspiratory flow) heated and humidified ambient air or air/oxygen to a patient in a peri-anaesthesia environment or experiencing a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), bronchiectasis, xerostomia, and mucositis]. The gases are delivered as part of noninvasive ventilation (NIV) to the patient's airway via the nose/mouth or a tracheostoma. It consists of a gas flow generator, a heating element, and humidification chamber. It is intended to be used by a healthcare provider on a spontaneously breathing patient.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040429050
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841737100775Vapotherm Inc.Tubing Adapter, 22mmTA-222026-06-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018561617NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561716NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561723NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561730NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561785NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561792NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561808NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561815NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561822NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561839NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561846NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561853NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561860NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
10197344010813HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-09-21
10197344016884HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016891HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016938HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016945HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016969HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016976HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016983HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016990HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
00841737100775Vapotherm Inc.VAPOTHERM, INC.BTT2026-06-23
09420012425911Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012425928Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012480729F&P OptiflowFISHER & PAYKEL HEALTHCARE LIMITEDBTT2025-11-07
00810083350561SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
00810083350585SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
10889483570906AirLife™AIRLIFEBTT2025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief ValveAIRLIFEBTT2025-02-20