HOPE Nebulizer - Adult Kit 11320

GUDID 00850008733000

Adult Nebulizer Kit with 6' Aerosol Tubing, Contains 10 Units

B&B Medical Technologies

Nebulizing system delivery set, single-use
Primary Device ID00850008733000
NIH Device Record Keyf2b32a82-07b0-477c-ba94-e443ca26f924
Commercial Distribution StatusIn Commercial Distribution
Brand NameHOPE Nebulizer - Adult Kit
Version Model Number11320
Catalog Number11320
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
GS100850008733000 [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 Date2019-05-21
Device Publish Date2019-05-13

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