FDA.reportPublic FDA data

Vapotherm

Primary DI
00841737105794
Brand
Vapotherm
Company
VAPOTHERM, INC.
Model
PF-OAM-NEL-BR
Device description
Precision Flow Oxygen Assist Module, NEL Unit Brazil
Published
2024-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2
QAVHigh Flow/High Velocity Humidified Oxygen Delivery DeviceAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841737105794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841737105794008417371057948417371057940841737105794

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory oxygen therapy pulse oximeter-regulator interfaceAn electrically-powered device designed to interface between a pulse oximeter probe and an electronic medical gas regulating unit during oxygen (O2) therapy, to continuously monitor haemoglobin oxygen saturation (SpO2), calculate the appropriate volume of O2 needed to be delivered to the patient based on SpO2 values, and transmit an electronic signal to the electronic O2 regulating unit. It includes a display, alarm(s), and integrated software; it does not come into direct contact with medical gases (i.e., does not include a gas regulator or tubing).

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
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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Primary DI, Brand, Company table
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10197344009596HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-10-17
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10197344009817HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-04-05
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10193489149302HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-05-01
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