FDA UDI
In Commercial Distribution
🇺🇸 United States
AspireAssist Connector-US
DI: 10857808005488
·
Model: 200-0019-US
·
ASPIRE BARIATRICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AspireAssist Connector-US
- Primary DI
- 10857808005488
- Version / Model
- 200-0019-US
- Catalog Number
- 200-0019-US
- 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
- 3459e864-8c7b-4898-a890-c1f886d0d95e
Device Description
Connector-US
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 | 10857808005488 | GS1 | ||||
| Package | 20857808005492 | GS1 | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 877-312-0007
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150024 | 000 |