InHealth Technologies; Blom-Singer

Basic Information

• Brand Name: InHealth Technologies; Blom-Singer
• Primary DI: 00813307012801
• Version / Model: BE 6220
• Company Name: Freudenberg Medical, LLC
• Labeler DUNS: 120981337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2017-01-01
• Public Version: 3
• Public Version Date: 2018-05-08
• Public Version Status: Update
• Public Device Record Key: 17896fcc-0218-4a6c-af90-6a0581b1aff3

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31065	Tracheostoma protector, reusable	A patient-worn device in the form of a patch, collar, or cloth designed to be fastened around the neck to protect a tracheostoma orifice against harmful external influences; it may also act as a tracheal air filter. It is typically made of textile or synthetic fabric materials and is regularly changed and cleaned; it is not intended to be used as a shower shield. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813307012801	GS1
Unit of Use	00848253002781	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]