AspireAssist A-Tube Kit

Basic Information

• Brand Name: AspireAssist A-Tube Kit
• Primary DI: 10857808005037
• Version / Model: 100-0011-LANG B
• Catalog Number: 100-0011-LANG B
• Company Name: ASPIRE BARIATRICS, INC.
• Labeler DUNS: 026281163
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-25
• Public Version: 4
• Public Version Date: 2019-10-07
• Public Version Status: Update
• Public Device Record Key: 40a846f6-142b-42a6-91a8-6ebb2efdc924

Device Description

AspireAssist A-Tube Kit

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: 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
OYF	Aspiration Therapy System	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
59038	Gastrostomy aspiration system stomach tube	A sterile, thin, flexible, hollow tube intended to be percutaneously implanted by endoscopic methods into the stomach of a morbidly obese (bariatric) patient (= 18 years) for the removal of a portion of stomach contents after meals by aspiration when used with a dedicated gravity kit that is the external portion of a gastrostomy aspiration system. The distal tip of the tube is inserted into the stomach and intended to attach to a stomal skin port; it is typically made of silicone and includes perforations to facilitate removal of food from the stomach. This is a single-patient device intended to be used for a limited period (single-use) before being explanted or replaced.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10857808005037	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P150024	000