Singer Laryngectomy Tube

Basic Information

• Brand Name: Singer Laryngectomy Tube
• Primary DI: 14063107101905
• Version / Model: SLT-0855
• Catalog Number: SLT-0855
• Company Name: Boston Medical Products, Inc.
• Labeler DUNS: 131855157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-31
• Public Version: 1
• Public Version Date: 2022-09-08
• Public Version Status: New
• Public Device Record Key: 5bb4d3d3-cb78-4a01-b467-22d573fffb4d

Device Description

Size: Size 8 x 55 mm

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KAC	Tube, Laryngectomy	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12292	Laryngectomy tube	A hollow device intended to maintain tracheostoma patency immediately after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis (narrowing) in the months following the procedure. It is a soft plastic or silicone curved/contoured tube, similar to a tracheostomy tube, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34063107101909	GS1	Carton	1	In Commercial Distribution
Primary	14063107101905	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size: 8
Length	50	Millimeter
Lumen/Inner Diameter	9.5	Millimeter
Outer Diameter	12.0	Millimeter

Storage Conditions

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