Portable Mesh Nebulizer

GUDID 06934325322278

FEELLIFE HEALTH INC.

Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable
Primary Device ID06934325322278
NIH Device Record Key970d31c1-abe7-426d-8390-7103c685ed7b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortable Mesh Nebulizer
Version Model NumberAir Kids
Company DUNS544431678
Company NameFEELLIFE HEALTH INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS106934325322278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-27
Device Publish Date2021-08-19

On-Brand Devices [Portable Mesh Nebulizer]

06934325388540Air Angel
06934325380353Air Pro IX
06934325376950Aerogo
06934325371733Air Mask II
06934325358475Air Pro
06934325349237Air Pro III
06934325338705Air Pro VIII
06934325322278Air Kids
06934325319490AeroCentre+
06934325301846Air Plus
06934325302263AirICU
06934325302249Air Mask D

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