InHealth Technologies; Katz

GUDID 00848253002637

Freudenberg Medical, LLC

ENT foreign body inflatable extractor

• Primary Device ID: 00848253002637
• NIH Device Record Key: c0855182-bff4-4b0c-a78b-556d7164702e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InHealth Technologies; Katz
• Version Model Number: FB 5000
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813307013594 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	00848253002637 [Primary]

FDA Product Code

• KBE: Snare, Nasal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-05-08
• Device Publish Date: 2017-01-01

Devices Manufactured by Freudenberg Medical, LLC

• 00848253002347 - InHealth Technologies; Blom-Singer: 2023-11-13 Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 8mm length
• 00848253002354 - InHealth Technologies; Blom-Singer®: 2023-11-13 Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 10mm length
• 00848253002361 - InHealth Technologies; Blom-Singer®: 2023-11-13 Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 12mm length
• 00848253002378 - InHealth Technologies; Blom-Singer®: 2023-11-13 Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 14mm length
• 00848253002385 - InHealth Technologies; Blom-Singer®: 2023-11-13 Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 8mm length
• 00848253002408 - InHealth Technologies; Blom-Singer®: 2023-11-13 Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 10mm length
• 00848253002606 - InHealth Technologies; Blom-Singer®: 2023-11-13 Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 12mm length
• 00848253003092 - InHealth Technologies; Blom-Singer®: 2023-11-13 Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 14mm length