Identity
- Trade Name
- Disposable Duralon Occlusion Balloon - 2 Lumen FDA UDI
- Generic Name
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
- Device Name
- Duralon Occlusion Balloon Four Size Variable Balloon 10.0mm, 13.0mm, 16.5mm, 20.0mm 7fr to 5fr Shaft Size x 200cm Catheter Length Distal Injection Port FDA UDI
- Model / Reference
- 1730 FDA UDI
- Description
- Duralon Occlusion Balloon Four Size Variable Balloon 10.0mm, 13.0mm, 16.5mm, 20.0mm 7fr to 5fr Shaft Size x 200cm Catheter Length Distal Injection Port FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813353010172 FDA UDI
- 510(k) Number
- K013737 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: ERCP catheter, balloon, non-electrical, stone-retrieval
Disposable Duralon Occlusion Balloon - 2 Lumen by TeleMed Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ERCP catheter, balloon, non-electrical, stone-retrieval.
- Retrieval Balloon short-wire compatible — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Anrei — Anrei Medical(HZ) Co., Ltd. · Class II
- Sterile Biliary Stone Retrieval Balloon Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class II
- DURAGLIDE — Conmed Corporation · Class II
- Single Use Balloon Dilator V (with knife) — Olympus Medical Systems Corporation · Class II
- Retrieval Balloon short-wire compatible — Micro-Tech (Nanjing) Co., Ltd. · Class II
- DURAGLIDE — Conmed Corporation · Class II
- Single Use 3-Lumen Extraction Balloon V — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K013737 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TeleMed Systems
Sources (1)
- FDA UDI dc2c4335-ef0f-4667-b7e9-002a4f06783e 34 fields · synced May 31, 2026