Vapotherm

GUDID 00841737103448

Precision Flow Oxygen Assist Module, Massimo

VAPOTHERM, INC.

Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator Respiratory oxygen therapy physiologic monitor/gas regulator
Primary Device ID00841737103448
NIH Device Record Keye8ec8fee-50ba-4bee-bc7f-92244d173107
Commercial Distribution StatusIn Commercial Distribution
Brand NameVapotherm
Version Model NumberPF-OAM-MAS
Company DUNS040429050
Company NameVAPOTHERM, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]
GS100841737103448 [Primary]

FDA Product Code

QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [Vapotherm]

00841737102915Precision Flow Plus UKIT, Japan
00841737102908Precision Flow HiVNI UKIT, Israel
00841737102892Precision Flow Plus Vapotherm Transfer Unit, DISS
00841737102885Precision Flow Vapotherm Transfer Unit, DISS Rental
00841737102878Precision Flow HiVNI UKIT, Mexico
00841737102861Precision Flow HiVNI UKIT, Chile
00841737102854Precision Flow HiVNI UKIT, Colombia
00841737102847Precision Flow HiVNI UKIT, Argentina
00841737102830Precision Flow Heliox UKIT, Switzerland
00841737102823Precision Flow Heliox UKIT, Italy
00841737102816Precision Flow Heliox UKIT, Israel
00841737102809Precision Flow Heliox UKIT, France
00841737102793Precision Flow Heliox UKIT, Spain
00841737102786Precision Flow Heliox UKIT, Canada
00841737102779Precision Flow Heliox UKIT, Mexico
00841737102762Precision Flow Heliox UKIT, Turkey
00841737102755Precision Flow Heliox UKIT, Germany
00841737102748Precision Flow Heliox UKIT, United Kingdom
00841737102731Precision Flow Heliox UKIT, US
00841737102724Precision Flow Classic UKIT, US
00841737102717Precision Flow HiVNI UKIT, Slovakia
00841737102700Precision Flow HiVNI UKIT, Sweden
00841737102694Precision Flow HiVNI UKIT, Poland
00841737102687Precision Flow HiVNI UKIT, Netherlands
00841737102670Precision Flow HiVNI UKIT, Italy
00841737102663Precision Flow HiVNI UKIT, France
00841737102656Precision Flow HiVNI UKIT, Spain
00841737102649Precision Flow HiVNI UKIT, Denmark
00841737102632Precision Flow HiVNI UKIT, Czech
00841737102625Precision Flow HiVNI UKIT, Switzerland
00841737102618Precision Flow HiVNI UKIT, Canada
00841737102601Precision Flow HiVNI UKIT, Belgium
00841737102595Precision Flow HiVNI UKIT, Australia
00841737102588Precision Flow HiVNI UKIT, Japan
00841737102571Precision Flow HiVNI UKIT, Turkey
00841737102564Precision Flow HiVNI UKIT, Germany
00841737102557Precision Flow HiVNI UKIT, United Kingdom
00841737102540Precision Flow HiVNI UKIT United States
00841737102533Precision Flow Plus UKIT Belgium
10841737102523VapoSoft Adult Nasal Cannula
10841737102516VapoSoft Pediatric Small Nasal Cannula
10841737102509Water Bottle Adapter and Disposable Patient Circuit High Flow
10841737102493Water Bottle Adapter and Disposable Patient Circuit Low Flow
00841737102489PF-VTU-BATTERY
00841737102472PF-Plus-UKIT-SE
10841737102417Brazil Disposable Patient Circuit Low Flow
10841737102394Brazil Disposable Patient Circuit HighFlow
00841737102380Pediatric/Adult Small Hi-VNI Nasal Cannula
00841737102366Adult Single Prong Hi-VNI Nasal Cannula
10841737102349Adult Hi-VNI Nasal Cannula

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