AccessGUDID - DEVICE: AspireAssist Skin-Port Installation Tool Kit-LANG A (10857808005327)

GUDID

Device Identifier (DI) Information

Brand Name: AspireAssist Skin-Port Installation Tool Kit-LANG A
Version or Model: 200-0021-LANG A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200-0021-LANG A
Company Name: ASPIRE BARIATRICS, INC.

Primary DI Number: 10857808005327
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 026281163 *Terms of Use

Device Description: Skin-Port Installation Tool Kit-LANG A

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
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.	Active	false

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: No
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: 04b96d85-0ca0-4cbc-a3a1-12ee6b038004
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 26, 2016