DeMucus™ Expiratory Muscle Trainer

GUDID 04716770342108

DeMucus™ Expiratory Muscle Trainer

BESMED HEALTH BUSINESS CORP.

Mechanical positive pressure airway secretion-clearing device
Primary Device ID04716770342108
NIH Device Record Keye8bbe9cb-39b9-4676-a42d-da19a25b4f14
Commercial Distribution StatusIn Commercial Distribution
Brand NameDeMucus™ Expiratory Muscle Trainer
Version Model NumberPE-34210
Company DUNS658023775
Company NameBESMED HEALTH BUSINESS CORP.
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 Datetrue
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
GS104716770342108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BWFSpirometer, Therapeutic (Incentive)

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 Date2017-12-28

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