AMS

GUDID 10822383524501

AMS, Power Neb

Drive Devilbiss Healthcare

Nebulizing system, non-heated
Primary Device ID10822383524501
NIH Device Record Key0359e358-45bf-4a32-98db-2e56efa66e80
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMS
Version Model Number18081-AMS
Company DUNS867673159
Company NameDrive Devilbiss Healthcare
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does n
Human Cell/Tissue Productfalse
Device Kittrue
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
GS100822383524504 [Primary]
GS110822383524501 [Package]
Contains: 00822383524504
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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