HOPE Nebulizer 11310

GUDID 00850008733024

Long-Term Medication Nebulizer with HELIOX Port

B&B Medical Technologies

Nebulizing system delivery set, single-use
Primary Device ID00850008733024
NIH Device Record Keye1ec9646-93b6-4fde-8f64-7a7497e1c41e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHOPE Nebulizer
Version Model Number11310
Catalog Number11310
Company DUNS829743579
Company NameB&B Medical Technologies
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850008733024 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-27
Device Publish Date2019-05-17

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