Disposable Duralon Occlusion Balloon - 2 Lumen
- Primary DI
- 00813353010158
- Brand
- Disposable Duralon Occlusion Balloon - 2 Lumen
- Company
- Telemed Systems
- Model
- 1710
- Device description
- Duralon Occlusion BalloonFour Size Variable Balloon10.0mm, 13.5mm, 16.5mm, 20.0mm7fr Shaft Size x 200cm Catheter LengthDistal Injection Port
- Published
- 2023-07-19
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K901427 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00813353010158 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00813353010158 | 00813353010158 | 813353010158 | 0813353010158 |
GMDN Terms#
| Term | Definition |
|---|---|
| ERCP catheter, balloon, non-electrical, stone-retrieval | A flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 017939239
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- No natural rubber latex
- true
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|---|---|---|---|---|
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