FDA UDI
In Commercial Distribution
🇺🇸 United States
BOEHRINGER® ViSiGi 3D® Calibration System size 40Fr Bypass/Short w/bulb
DI: 10816286020871
·
Model: 5240SB
·
BOEHRINGER LABORATORIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BOEHRINGER® ViSiGi 3D® Calibration System size 40Fr Bypass/Short w/bulb
- Primary DI
- 10816286020871
- Version / Model
- 5240SB
- Company Name
- BOEHRINGER LABORATORIES, LLC
- Labeler DUNS
- 079991657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-01
- Public Version
- 4
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 5002434f-f706-4521-b059-3d25f3f67002
Device Description
ViSiGi 3D® Calibration System size 40Fr Bypass/Short w/bulb
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 |
|---|---|---|---|---|
| 44686 | Gastric calibration tube | A thin, flexible, hollow cylinder with an inflatable balloon at the distal end designed to be inserted into a patient's stomach through the mouth and oesophagus to create and size a gastric pouch typically for a bariatric gastric surgical procedure (e.g., sleeve gastrectomy, gastric banding). The proximal end may include a check valve and connects to a syringe, typically included, intended to inflate the balloon to a predetermined volume; fluid suction/irrigation ports are provided at the distal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10816286020871 | GS1 | ||||
| Package | 30816286020875 | GS1 | Box | 5 | In Commercial Distribution | |
| Package | 50816286020879 | GS1 | Carton | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- 610-278-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130483 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 40 | French |