HEPA Filter

GUDID 10709078002240

*HEPA Filter with Port and Elbow (6224)

WESTMED, INC.

Heat/moisture exchanger/microbial filter, non-sterile
Primary Device ID10709078002240
NIH Device Record Key587edfd3-0cce-4e40-8851-5f29566644fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEPA Filter
Version Model NumberF300A
Company DUNS092673953
Company NameWESTMED, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100709078002243 [Primary]
GS110709078002240 [Package]
Contains: 00709078002243
Package: [50 Units]
In Commercial Distribution

FDA Product Code

MODAccessory To Continuous Ventilator (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-30

On-Brand Devices [HEPA Filter]

10709078002240*HEPA Filter with Port and Elbow (6224)
00709078001567w/o CO2 Port
10709078014007Hepa Filter W/CO2 port (TwinMed)

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