InHealth Technologies; Blom-Singer

GUDID 00813307012078

Freudenberg Medical, LLC

Laryngectomy tube, non-sterile Laryngectomy tube, non-sterile
Primary Device ID00813307012078
NIH Device Record Key0863b3af-9bea-4440-b5b9-d4854af00389
Commercial Distribution StatusIn Commercial Distribution
Brand NameInHealth Technologies; Blom-Singer
Version Model NumberBE 6305F
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 Usefalse
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


Device Identifiers

Device Issuing AgencyDevice ID
GS100813307012078 [Primary]
GS100813307012078 [Primary]

FDA Product Code

KACTube, Laryngectomy
KACTube, Laryngectomy


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]

00813307014744IN 4066
00813307014737IN 4065
00813307014720IN 4064
00813307014508IN 1614-LETO
00813307014492IN 2014-LETO
00813307014485IN 1612-LETO
00813307014478IN 2012-LETO
00813307014461IN 1610-LETO
00813307014454IN 2010-LETO
00813307014447IN 1608-LETO
00813307014430IN 2008-LETO
00813307014423IN 1606-LETO
00813307014416IN 2006-LETO
00813307014409IN 1604-LETO
00813307014393IN 2004-LETO
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00813307013105BE 2036
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00813307013075BE 8000
00813307013068BE 6055
00813307012801BE 6220
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00813307012788BE 6210
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00813307012603BE 6046
00813307012597BE 6045
00813307012580BE 6038-P
00813307012573BE 6039-P
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00813307012092BE 6399
00813307012085BE 6398
00813307012078BE 6305F
00813307012061BE 6304F
00813307012054BE 6303F

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