Montgomery® Salivary Bypass Tube

Basic Information

• Brand Name: Montgomery® Salivary Bypass Tube
• Primary DI: 14063107100304
• Version / Model: 322080
• Catalog Number: 322080
• Company Name: Boston Medical Products, Inc.
• Labeler DUNS: 131855157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-29
• Public Version: 1
• Public Version Date: 2022-10-07
• Public Version Status: New
• Public Device Record Key: 0c0b5958-ed4d-41ef-bfb4-0a1e374feea6

Device Description

Size: 8 mm; Type: Clear

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: Yes
• MRI Safety: MR Safe
• 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
KCF	Dilator, Esophageal, Ent	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43684	Polymeric oesophageal stent, non-bioabsorbable	A sterile, non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to temporarily maintain luminal patency in strictures and achalasia, seal fistulas, and/or to treat other lesions (e.g., anastomotic leaks). It is a mesh structure, which may or may not be covered/lined, and is made entirely of a synthetic polymer(s) (e.g., silicone). It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34063107100308	GS1	Carton	1	In Commercial Distribution
Primary	14063107100304	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K812305	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Funnel OD: 33 Millimeter
Length	191	Millimeter
Outer Diameter	8	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight