Identity
- Trade Name
- M-Drain FDA UDI
- Generic Name
- Multi-purpose percutaneous abdominothoracic drainage catheter FDA UDI
- Device Name
- The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections. "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 (5F~16F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either D105/D107/D110/D112/D130 (Direct Access) or D120 (Seldinger Type) depending on the method used to provide access." FDA UDI
- Model / Reference
- D10512025 FDA UDI
- Description
- The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections. "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 (5F~16F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either D105/D107/D110/D112/D130 (Direct Access) or D120 (Seldinger Type) depending on the method used to provide access." FDA UDI
Identifiers
- Catalog Number
- D10512025 FDA UDI
- Primary DI / UDI-DI
- 15711055000700 FDA UDI
- 510(k) Number
- K033862 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Multi-purpose percutaneous abdominothoracic drainage catheter 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 — 25 Centimeter FDA UDICatheter Gauge — 12 French FDA UDI
Category: Multi-purpose percutaneous abdominothoracic drainage catheter
M-Drain by Mermaid Medical A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose percutaneous abdominothoracic drainage catheter.
- ACCEL® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class I
- ACCEL® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
- SKATER™ All-Purpose and Nephrostomy Drainage Set — Argon Medical Devices, Inc. · Class I
- ACCEL® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class I
- Argyle — Cardinalhealth · Class II
- ACCEL® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class II
- Cook — COOK INCORPORATED · U
- 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 681919fe-576d-4616-927c-b7b63e536586 38 fields · synced May 30, 2026