InHealth Technologies; Blom-Singer; Classic

GUDID 00813307011033

Freudenberg Medical, LLC

Tracheoesophageal speech valve, indwelling, sterile
Primary Device ID00813307011033
NIH Device Record Keya25a5cda-bfe9-4752-a927-698410a9f454
Commercial Distribution StatusIn Commercial Distribution
Brand NameInHealth Technologies; Blom-Singer; Classic
Version Model NumberIN 2010-SO
Company DUNS120981337
Company NameFreudenberg Medical, LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-477-5969
EmailInHealth@inhealth.com
Phone800-477-5969
EmailInHealth@inhealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813307011033 [Primary]

FDA Product Code

EWLProsthesis, Laryngeal (Taub)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-08
Device Publish Date2018-01-01

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

00813307014577IN 1612-IR
00813307014560IN 1610-IR
00813307014553IN 1608-IR
00813307014522IN 1606-IR
00813307014515IN 1606-LEIR
00813307014324IN 1608-LEIR
00813307014317IN 2008-LEIR
00813307014300IN 2006-LEIR
00813307014294IN 1604-LEIR
00813307014287IN 2004-LEIR
00813307014270IN 1614-LF
00813307014263IN 2014-LF
00813307014256IN 1612-LF
00813307014249IN 2012-LF
00813307014232IN 1610-LF
00813307014225IN 2010-LF
00813307014218IN 1608-LF
00813307014201IN 2008-LF
00813307014195IN 1606-LF
00813307014188IN 2006-LF
00813307014171IN 1604-LF
00813307014164IN 2004-LF
00813307014157IN 1614-LEF
00813307014140IN 1612-LEF
00813307014133IN 1610-LEF
00813307014126IN 1608-LEF
00813307014119IN 1606-LEF
00813307014102IN 1604-LEF
00813307013938IN 1607-LESL
00813307013921IN 2007-LESL
00813307013914IN 1605-LESL
00813307013907IN 2005-LESL
00813307013877IN 1609-SL
00813307013860IN 1607-SL
00813307013853IN 1605-SL
00813307011422IN 2012-IR
00813307011415IN 2010-IR
00813307011408IN 2008-IR
00813307011392IN 2006-IR
00813307011354IN 2009-SL
00813307011347IN 2007-SL
00813307011330IN 2005-SL
00813307011323IN 2014-LEF
00813307011316IN 2012-LEF
00813307011309IN 2010-LEF
00813307011293IN 2008-LEF
00813307011286IN 2006-LEF
00813307011262IN 2004-LEF
00813307011248IN 2020-NS
00813307011231IN 2018-NS

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