DEVICE: AspireAssist Starter Kit, Blue-LANG A (10857808005167)
Device Identifier (DI) Information
AspireAssist Starter Kit, Blue-LANG A
100-0017-LANG A
In Commercial Distribution
100-0017-LANG A
ASPIRE BARIATRICS, INC.
100-0017-LANG A
In Commercial Distribution
100-0017-LANG A
ASPIRE BARIATRICS, INC.
Starter Kit, Blue-LANG A
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
36254b20-bfb6-434a-b821-716e2812ef96
July 06, 2018
3
July 25, 2016
July 06, 2018
3
July 25, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
877-312-0007
quality@aspirebariatrics.com
quality@aspirebariatrics.com