AccessGUDID - DEVICE: AspireAssist A-Tube Kit (10857808005037)

GUDID

Device Identifier (DI) Information

Brand Name: AspireAssist A-Tube Kit
Version or Model: 100-0011-LANG B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100-0011-LANG B
Company Name: ASPIRE BARIATRICS, INC.

Primary DI Number: 10857808005037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 026281163 *Terms of Use

Device Description: AspireAssist A-Tube Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OYF	Aspiration Therapy System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150024	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 40a846f6-142b-42a6-91a8-6ebb2efdc924
Public Version Date: October 07, 2019
Public Version Number: 4
DI Record Publish Date: July 25, 2016