DRIVEMEDICAL

GUDID 00822383228693

RespiratoryNebs Product Description: Pacifica 2 Nebulizer,1/ea

Drive Devilbiss Healthcare

Nebulizing system, non-heated
Primary Device ID00822383228693
NIH Device Record Keyc43fad2c-6945-481b-a8c4-a591a025b700
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRIVEMEDICAL
Version Model Number18062
Company DUNS867673159
Company NameDrive Devilbiss Healthcare
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
GS100822383228693 [Primary]
GS150822383228698 [Package]
Package: [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JCXAPPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-16
Device Publish Date2016-11-07

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