InHealth Technologies; Blom-Singer

GUDID 00813307012665

Freudenberg Medical, LLC

Stomal appliance skin-adherent patch, non-sterile

• Primary Device ID: 00813307012665
• NIH Device Record Key: 68808704-b55d-49b7-b322-550c71f89826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InHealth Technologies; Blom-Singer
• Version Model Number: BE 6044
• Company DUNS: 120981337
• Company Name: Freudenberg Medical, LLC
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813307012665 [Primary]
GS1	00848253002552 [Unit of Use]

FDA Product Code

• KGX: Tape And Bandage, Adhesive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-01

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

• 00813307014744: IN 4066
• 00813307014737: IN 4065
• 00813307014720: IN 4064
• 00813307014508: IN 1614-LETO
• 00813307014492: IN 2014-LETO
• 00813307014485: IN 1612-LETO
• 00813307014478: IN 2012-LETO
• 00813307014461: IN 1610-LETO
• 00813307014454: IN 2010-LETO
• 00813307014447: IN 1608-LETO
• 00813307014430: IN 2008-LETO
• 00813307014423: IN 1606-LETO
• 00813307014416: IN 2006-LETO
• 00813307014409: IN 1604-LETO
• 00813307014393: IN 2004-LETO
• 00813307013181: BE 2052
• 00813307013174: BE 2051
• 00813307013112: BE 6096
• 00813307013105: BE 2036
• 00813307013099: BE 6036
• 00813307013075: BE 8000
• 00813307013068: BE 6055
• 00813307012801: BE 6220
• 00813307012795: BE 6215
• 00813307012788: BE 6210
• 00813307012771: BE 6200
• 00813307012740: BE 6048
• 00813307012689: BE 6035
• 00813307012672: BE 6034
• 00813307012665: BE 6044
• 00813307012658: BE 6043
• 00813307012641: BE 6042
• 00813307012634: BE 6041
• 00813307012603: BE 6046
• 00813307012597: BE 6045
• 00813307012580: BE 6038-P
• 00813307012573: BE 6039-P
• 00813307012566: BE 6039
• 00813307012559: BE 6038
• 00813307012153: BE 6405
• 00813307012146: BE 6404
• 00813307012139: BE 6403
• 00813307012122: BE 6402
• 00813307012115: BE 6401
• 00813307012108: BE 6400
• 00813307012092: BE 6399
• 00813307012085: BE 6398
• 00813307012078: BE 6305F
• 00813307012061: BE 6304F
• 00813307012054: BE 6303F