Vapotherm

Primary DI
00841737104384
Brand
Vapotherm
Company
VAPOTHERM, INC.
Model
FELIX-1-IN
Device description
Felix-1, India Version
Published
2021-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
CBDBottle, Collection, Breathing System (Calibrated)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBDBottle, Collection, Breathing System (Calibrated)General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841737104384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841737104384008417371043848417371043840841737104384

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure face tentA mask-like enclosure, with tubing for connection to a hospital suction system, designed to rest against the chin of a patient while remaining away from the face, and intended to create a negative pressure area near the patient’s nose and mouth to suction exhaled air and reduce the dispersal of potentially infectious particulates into the local environment. It is typically used while treating patients with airborne or droplet-transmitted infectious diseases (e.g., COVID-19). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040429050
Device count
1
Premarket exempt
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10788942595002PortexICU MEDICAL, INC.CBD2016-10-11
50788942595000PortexICU MEDICAL, INC.CBD2016-10-11