FDA.reportPublic FDA data

Vapotherm

Primary DI
10841737102998
Brand
Vapotherm
Company
VAPOTHERM, INC.
Model
PF-ADPC-High
Device description
Aerosol Disposable Patient Circuit, High Flow
Published
2019-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
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
10841737102998PackageGS13In Commercial Distribution
00841737102991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084173710299810841737102998
00841737102991008417371029918417371029910841737102991

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
false
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
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

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10197344016990HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
00841737100775Vapotherm Inc.VAPOTHERM, INC.BTT2026-06-23
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