Air Next

GUDID 07350002630006

NuvoAir AB

Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional
Primary Device ID07350002630006
NIH Device Record Keyd64b818e-6eeb-412f-ab0b-3c52dde95fe5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAir Next
Version Model NumberNVD-02
Company DUNS352418477
Company NameNuvoAir AB
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 Numbertrue
Manufacturing Datetrue
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
GS107350002630006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZGSpirometer, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-28
Device Publish Date2024-03-20

On-Brand Devices [Air Next]

17350002630027NVD-01
07350002630006NVD-02

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