Identity
- Trade Name
- M-Drain FDA UDI
- Generic Name
- Biliary drain FDA UDI
- Device Name
- The catheter is designed for percutaneous biliary drainage. The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These kits are classified according to the catheter size (8F~14F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either D140 or D145 (with or without locking pigtail). FDA UDI
- Model / Reference
- D14510040 FDA UDI
- Description
- The catheter is designed for percutaneous biliary drainage. The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These kits are classified according to the catheter size (8F~14F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either D140 or D145 (with or without locking pigtail). FDA UDI
Identifiers
- Catalog Number
- D14510040 FDA UDI
- Primary DI / UDI-DI
- 15711055000496 FDA UDI
- 510(k) Number
- K033862 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Biliary drain 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
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Dimensions & Sizes
- Size
- Length — 40 Centimeter FDA UDICatheter Gauge — 10 French FDA UDI
Category: Biliary drain
M-Drain by Mermaid Medical A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biliary drain.
- PLASTİ-MED — Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti. · Class IIa
- DRENTECH PUMP 400 ML SET SERBATOIO E DRENAGGIO TONDO C/AGO CH 10 — Redax S.p.A. · Class IIa
- Flexima™ — Boston Scientific · Class II
- LMI BILUMEN BILIARY CATHETER DISTAL — LUCAS MEDICAL INC · Class II
- Redondrain PU Ch.12 Länge 800 mm / Perforation 150 mm, graduiert, röntgenfähig steril, gewickelt, DEHP frei — Primed Halberstadt Medizintechnik GmbH · Class IIa
- Biliary Plastic Stent — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Biliary Plastic Stent Set — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Cook — COOK INCORPORATED · U
Cleared under the same submission
K033862 also covers:
- M-Drain — Mermaid Medical A/S
- M-Drain — Mermaid Medical A/S
- M-Drain — Mermaid Medical A/S
- M-Drain — Mermaid Medical A/S
- M-Drain — Mermaid Medical A/S
- M-Drain — Mermaid Medical A/S
- M-Drain — Mermaid Medical A/S
- M-Drain — Mermaid Medical A/S
- M-Drain — Mermaid Medical A/S
- M-Drain — Mermaid Medical A/S
- M-Drain — Mermaid Medical A/S
- M-Drain — Mermaid Medical A/S
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 |
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Manufacturer
- Manufacturer
- Mermaid Medical A/S
Sources (1)
- FDA UDI ffd2549e-59dc-40af-98d2-92e570515e91 38 fields · synced May 30, 2026