Encore Respiratory

GUDID 00822383295213

Encore Respiratory, Sportneb

Drive Devilbiss Healthcare

Nebulizing system, non-heated
Primary Device ID00822383295213
NIH Device Record Key4652fb69-11ef-49e6-8d66-95858ab234d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameEncore Respiratory
Version Model Number3050-2-ERPN
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
GS100822383295213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTICompressor, air, portable

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.