InHealth Technologies; Blom-Singer; HumidiFilter

GUDID 00813307011804

Freudenberg Medical, LLC

Heat/moisture exchanger, single-use
Primary Device ID00813307011804
NIH Device Record Key028e7f9a-c198-4ffe-9a27-f392f0b57c7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameInHealth Technologies; Blom-Singer; HumidiFilter
Version Model NumberBE 1030
Company DUNS120981337
Company NameFreudenberg Medical, LLC
Device Count10
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-477-5969
EmailInHealth@inhealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813307011804 [Package]
Contains: 00848253002415
Package: [3 Units]
In Commercial Distribution
GS100848253002415 [Primary]
GS100848253002422 [Unit of Use]

FDA Product Code

BYDCondenser, Heat And Moisture (Artificial Nose)

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 Date2017-01-01

On-Brand Devices [InHealth Technologies; Blom-Singer; HumidiFilter]

00813307011781BE 1010
00813307011804BE 1030

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