FDA.reportPublic FDA data

Vapotherm

Primary DI
10841737102035
Brand
Vapotherm
Company
VAPOTHERM, INC.
Model
43000576
Device description
HVT 2.0 Patient Air Filter
Published
2022-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
10841737102035PackageGS15In Commercial Distribution
00841737102038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084173710203510841737102035
00841737102038008417371020388417371020380841737102038

GMDN Terms#

Term, Definition table
TermDefinition
Professional high-flow respiratory unitA mains electricity (AC-powered) device designed to deliver high-flow (exceeding peak inspiratory flow) 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 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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 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

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