FDA UDI
In Commercial Distribution
🇺🇸 United States
AspireAssist A-Tube Pack
DI: 10857808005013
·
Model: 200-0044
·
ASPIRE BARIATRICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AspireAssist A-Tube Pack
- Primary DI
- 10857808005013
- Version / Model
- 200-0044
- Catalog Number
- 200-0044
- 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
- 4
- Public Version Date
- 2019-10-07
- Public Version Status
- Update
- Public Device Record Key
- c5e1fdba-0e88-4ee3-8a8c-7e8920a69fe1
Device Description
A-Tube Pack
Device Characteristics
- Single Use
- Yes
- 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
- MR Safe
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10857808005013 | GS1 |
Customer Contacts
- Phone
- 877-312-0007
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150024 | 000 |