Carolina Breathing

GUDID 00822383295169

Carolina Breathing, Sportneb

Drive Devilbiss Healthcare

Nebulizing system, non-heated
Primary Device ID00822383295169
NIH Device Record Keyde0bf001-e212-4f17-b259-e6f35284a62c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarolina Breathing
Version Model Number3050-2-CABRPN
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
GS100822383295169 [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

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