3B Medical, Inc. Qube Compressor Nebulizer

GUDID 00817783020251

Nebulisers are devices used to deliver atomised particles of drug to the airways via compressed air

3B MEDICAL, INC.

Ultrasonic nebulizing system Ultrasonic nebulizing system
Primary Device ID00817783020251
NIH Device Record Keya9d3422f-85a4-4355-a0b8-9cdf67cef640
Commercial Distribution StatusIn Commercial Distribution
Brand Name3B Medical, Inc. Qube Compressor Nebulizer
Version Model NumberQN1000
Company DUNS078517316
Company Name3B MEDICAL, 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817783020251 [Primary]

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-10-13

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