InHealth Technologies; Blom-Singer

Basic Information

• Brand Name: InHealth Technologies; Blom-Singer
• Primary DI: 00848253000954
• Version / Model: FM 1004
• Company Name: Freudenberg Medical, LLC
• Labeler DUNS: 120981337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-01
• Public Version: 3
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: 359ea862-9b04-48c4-9086-ba446b38ccad

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61420	Hypopharyngeal fistula occluder	A device intended to be used for the non-surgical short-term (i.e., < 30 days) occlusion of a fistula in the upper end of the oesophagus (hypopharynx), typically where the fistula has an external opening, to prevent leakage of oesophageal content. It consists of two disk-like flanges (one being positioned on the inside of the pharynx and one on the outside) attached to a single- or double-beaded stem, and is made of silicone and plastic materials. It is inserted and removed using a dedicated device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848253000954	GS1

Customer Contacts

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