InHealth Technologies; Blom-Singer; Hydrofit

GUDID 00848253003597

Freudenberg Medical, LLC

Tracheostomy base plate, single-use

• Primary Device ID: 00848253003597
• NIH Device Record Key: 48dd2d08-10d8-4120-aaae-b0dd2d8fd96e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InHealth Technologies; Blom-Singer; Hydrofit
• Version Model Number: BE 6085
• Company DUNS: 120981337
• Company Name: Freudenberg Medical, LLC
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848253003511 [Package]; Contains: 00848253003528; Package: [30 Units]; In Commercial Distribution
GS1	00848253003528 [Primary]
GS1	00848253003597 [Package]; Contains: 00848253003528; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• BYD: Condenser, Heat And Moisture (Artificial Nose)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-19
• Device Publish Date: 2019-09-11

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

• 00848253003573: BE 6087
• 00848253003580: BE 6086
• 00848253003597: BE 6085