Balloon Extractor

Basic Information

• Brand Name: Balloon Extractor
• Primary DI: 00855364004092
• Version / Model: BEX
• Company Name: MAR-MED INC.
• Labeler DUNS: 176664068
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 1
• Public Version Date: 2020-10-01
• Public Version Status: New
• Public Device Record Key: b642437c-0f92-4d37-87d0-78c1cf3f6ecf

Device Description

Balloon Nasal Foreign Body Extractor

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KBE	Snare, Nasal	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62097	ENT foreign body inflatable extractor	A non-sterile, manual device intended to be inserted into the nasal or ear canal for the extraction of a foreign body/debris. It is a thin tube with a proximal inflation mechanism (e.g., a syringe) and a distal balloon. The distal end is intended to be navigated past the foreign body, after which the balloon is inflated and then pulled back along the canal to dislodge the foreign body. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10855364004099	GS1	Box	10	In Commercial Distribution
Primary	00855364004092	GS1

Customer Contacts

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