Sou

GUDID 10822383529117

SOU, Pacifica Elite Nebulizer

Drive Devilbiss Healthcare

Nebulizing system, non-heated
Primary Device ID10822383529117
NIH Device Record Key30e966f1-11a0-4774-bf3b-a331e3d0cff8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSou
Version Model Number18070-SOU
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
GS100822383529110 [Primary]
GS110822383529117 [Package]
Contains: 00822383529110
Package: [6 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

Devices Manufactured by Drive Devilbiss Healthcare

00822383030333 - Drive2025-09-11
00822383000190 - Drive2025-09-10 35" BRNWOOD BEDEND W/SC05,OSLO FM,EA
00822383000206 - Drive2025-09-10 35" MILL CRK BEDEND W/SC05, OSLO OAK,EA
00822383000213 - Drive2025-09-10 35" MILL CRK BEDEND W/SC05,OSLO CHERRY,EA
00822383000220 - Drive2025-09-10 35" MILL CRK BEDEND W/SC05,OSLO FM,EA
00822383000237 - Drive2025-09-10 42" BRNWOOD BEDEND W/SC05,OSLO OAK,EA
00822383000244 - Drive2025-09-10 42" BRNWOOD BEDEND W/SC05,OSLO CHERRY,EA
00822383000251 - Drive2025-09-10 42" BRNWOOD BEDEND W/SC05,OSLO FM,EA

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