HCM

GUDID 10822383522712

HCM, Power Neb

Drive Devilbiss Healthcare

Nebulizing system, non-heated
Primary Device ID10822383522712
NIH Device Record Keyd6c7ae1d-8ee8-4d89-9b4d-492075336cbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameHCM
Version Model Number18081-HCM
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 Kittrue
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
GS100822383522715 [Primary]
GS110822383522712 [Package]
Contains: 00822383522715
Package: [6 Units]
In Commercial Distribution

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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