InHealth Technologies; Blom-Singer; Accufit

GUDID 00848253003610

Freudenberg Medical, LLC

Tracheostomy base plate, single-use
Primary Device ID00848253003610
NIH Device Record Key84308786-dcf6-4072-b881-e60e82315678
Commercial Distribution StatusIn Commercial Distribution
Brand NameInHealth Technologies; Blom-Singer; Accufit
Version Model NumberBE 6083
Company DUNS120981337
Company NameFreudenberg Medical, LLC
Device Count1
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
GS100848253003467 [Package]
Contains: 00848253003498
Package: [30 Units]
In Commercial Distribution
GS100848253003498 [Primary]
GS100848253003610 [Package]
Contains: 00848253003498
Package: [6 Units]
In Commercial Distribution

FDA Product Code

BYDCondenser, Heat And Moisture (Artificial Nose)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-19
Device Publish Date2019-09-11

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

00848253003603BE 6084
00848253003610BE 6083
00848253003627BE 6082

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