InHealth Technologies; Blom-Singer

GUDID 00813307012597

Freudenberg Medical, LLC

Stomal appliance skin-adherent patch, non-sterile Stomal appliance skin-adherent patch, non-sterile
Primary Device ID00813307012597
NIH Device Record Key44756f43-59ef-41d3-8525-1654249322db
Commercial Distribution StatusIn Commercial Distribution
Brand NameInHealth Technologies; Blom-Singer
Version Model NumberBE 6045
Company DUNS120981337
Company NameFreudenberg Medical, LLC
Device Count30
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


Device Identifiers

Device Issuing AgencyDevice ID
GS100813307012597 [Primary]
GS100813307012597 [Primary]
GS100848253002538 [Unit of Use]
GS100848253002538 [Unit of Use]

FDA Product Code

KGXTape And Bandage, Adhesive
KGXTape And Bandage, Adhesive


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 Date2018-01-01

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
00813307013181BE 2052
00813307013174BE 2051
00813307013112BE 6096
00813307013105BE 2036
00813307013099BE 6036
00813307013075BE 8000
00813307013068BE 6055
00813307012801BE 6220
00813307012795BE 6215
00813307012788BE 6210
00813307012771BE 6200
00813307012740BE 6048
00813307012689BE 6035
00813307012672BE 6034
00813307012665BE 6044
00813307012658BE 6043
00813307012641BE 6042
00813307012634BE 6041
00813307012603BE 6046
00813307012597BE 6045
00813307012580BE 6038-P
00813307012573BE 6039-P
00813307012566BE 6039
00813307012559BE 6038
00813307012153BE 6405
00813307012146BE 6404
00813307012139BE 6403
00813307012122BE 6402
00813307012115BE 6401
00813307012108BE 6400
00813307012092BE 6399
00813307012085BE 6398
00813307012078BE 6305F
00813307012061BE 6304F
00813307012054BE 6303F

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