FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Obalon Aspiration Adapter
DI: 00859810006265
·
Model: 6100-0004
·
Reshape Lifesciences Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Obalon Aspiration Adapter
- Primary DI
- 00859810006265
- Version / Model
- 6100-0004
- Company Name
- Reshape Lifesciences Inc.
- Labeler DUNS
- 022894714
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-09
- Public Version
- 5
- Public Version Date
- 2023-09-01
- Public Version Status
- Update
- Public Device Record Key
- 1b12c782-29fc-48d4-ba76-96a5d30514bf
- Distribution End Date
- 2020-03-02
Device Description
Aspiration adapter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64467 | Luer/non-ISO80369-standardized linear connector, single-use | A small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, bayonet, collet, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing or an external puncturing component. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20859810006269 | GS1 | 2 | Not in Commercial Distribution | 2020-03-02 | |
| Package | 10859810006262 | GS1 | 5 | Not in Commercial Distribution | 2020-03-02 | |
| Primary | 00859810006265 | GS1 |
Customer Contacts
- Phone
- 1-844-362-2566
- [email protected]