FDA.reportPublic FDA data

Vapotherm

Primary DI
00841737103103
Brand
Vapotherm
Company
VAPOTHERM, INC.
Model
OAM-UKIT-DE
Device description
Precision Flow Oxygen Assist Module, Germany UKIT
Published
2019-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841737103103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841737103103008417371031038417371031030841737103103

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory oxygen therapy physiologic monitor/gas regulatorAn electrically-powered unit designed to be connected to a pulse oximeter sensor and used during the administration of oxygen (O2) to a spontaneously breathing patient, for: 1) continuous monitoring of physiologic parameters, especially haemoglobin oxygen saturation (SpO2); and 2) dynamic regulation of the amount of O2 delivered to the patient based on physiological parameter measurements. It is a computerized unit designed to interface between the O2 source and the patient and includes monitoring functionality, a graphic display, alarm(s), electronic gas valve, and integrated software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040429050
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
10841737102950VapothermUNICORN-ADULT2025-03-27
00841737102960VapothermUNICORN-PED2025-03-27
00841737105831VapothermHVT-BUYOUT2025-03-11
00841737105817VapothermHVT-UPGRADE-MODO2024-09-09
00841737105800VapothermHVT-UKIT-PH2024-08-26
00841737105787VapothermPF-OAM-MAS-BR2024-06-10
00841737105794VapothermPF-OAM-NEL-BR2024-06-10
00841737105763VapothermPF-OAM-MAS-UKIT-BR2024-06-03
00841737105770VapothermPF-OAM-NEL-UKIT-BR2024-06-03
00841737105725VapothermHPF-TA-22-BR2023-11-16
00841737105749VapothermHVT-BAT-BR2023-11-16
10841737105753VapothermHVT-DPC-BR2023-11-16
00841737105695VapothermHVT-VTU-OUS-BR2023-10-24
00841737105701VapothermHVT-UKIT-BR2023-10-24
00841737105718VapothermHVT20-UNIT-VTU-BR2023-10-24
00841737105664VapothermHVT20-UNIT-FLM2023-09-25
00841737105671VapothermHVT20-NEL-FLM2023-09-25
00841737105688VapothermHVT20-MAS-FLM2023-09-25
00841737105657VapothermPF-C-PLUS-FLM2023-05-30
00841737105633VapothermHVT-UKIT-CA2023-05-11

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