FDA UDI
In Commercial Distribution
🇺🇸 United States
BOEHRINGER® Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System
DI: 10816286020659
·
Model: 5250
·
BOEHRINGER LABORATORIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BOEHRINGER® Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System
- Primary DI
- 10816286020659
- Version / Model
- 5250
- Company Name
- BOEHRINGER LABORATORIES, LLC
- Labeler DUNS
- 079991657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 4
- Public Version Date
- 2021-04-02
- Public Version Status
- Update
- Public Device Record Key
- 37726d97-c993-4ee4-9997-be51d1cd58e0
Device Description
Accessory Bulb for ViSiGi 3D™ Sleeve Gastrectomy Calibration System
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
- Yes
- 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 |
|---|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37883 | General positive-pressure manual hand pump | A hand-operated manual device designed to draw in ambient air and expel the air from a connected nozzle to inflate an object, such as an inflatable mattresses or patient head support rings; it is not intended to be used with invasive devices. It is typically designed as a bicycle pump, a stirrup pump, or a large syringe-like pump, and may be used in the home or healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30816286020653 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 10816286020659 | GS1 | ||||
| Package | 50816286020657 | GS1 | Carton | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- 610-278-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130483 | 000 |