Nucara Home

GUDID 10822383295456

Nucara Home, Sportneb

Drive Devilbiss Healthcare

Nebulizing system, non-heated
Primary Device ID10822383295456
NIH Device Record Keye8a43a83-4cc8-4d83-b9b8-e736a342404d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNucara Home
Version Model Number3050-2-NUCARA
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
GS100822383295459 [Primary]
GS110822383295456 [Package]
Contains: 00822383295459
Package: [10 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

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