AspireAssist Companion, Blue-LANG A

Basic Information

• Brand Name: AspireAssist Companion, Blue-LANG A
• Primary DI: 10857808005099
• Version / Model: 100-0013-LANG A
• Catalog Number: 100-0013-LANG A
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f2e4ffed-1da5-4086-b4aa-f7323f190b73

Device Description

Companion, Blue-LANG A

Device Characteristics

• Single Use: No
• 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: No
• 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
59039	Gastrostomy aspiration system gravity set	A collection of non-sterile devices designed as the external portion of a gastrostomy aspiration system intended to be used post-surgery by the patient after implantation of the stomach tube for the removal of a portion of stomach contents after meals, by aspiration, to achieve portion control and subsequently weight loss in a morbidly obese (bariatric) patient (= 18 years). It typically consists of a connector (connects to the stomal skin port), water reservoir, drain tube, and control valves to facilitate alternating water infusion and aspiration by gravity. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10857808005099	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P150024	000