Identity
- Trade Name
- M-Drain FDA UDI
- Generic Name
- Interventional radiology percutaneous-access kit, single-use FDA UDI
- Device Name
- The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire where the puncture is performed with a 21G needle (fine needle). FDA UDI
- Model / Reference
- DS2020400 FDA UDI
- Description
- The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire where the puncture is performed with a 21G needle (fine needle). FDA UDI
Identifiers
- Catalog Number
- DS2020400 FDA UDI
- Primary DI / UDI-DI
- 15711055001899 FDA UDI
- 510(k) Number
- K071330 FDA UDI
- FDA Product Code
- DRE FDA UDI
- GMDN Term
- Interventional radiology percutaneous-access kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1310 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 — 20 Centimeter FDA UDICatheter Gauge — 6 French FDA UDI
Category: Interventional radiology percutaneous-access kit, single-use
M-Drain by Mermaid Medical A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Interventional radiology percutaneous-access kit, single-use.
- EXTesia — Curatia Medical Limited · Class IIa
- SWL-Pathfinder — SWL Medizin GmbH · Class III
- Mini Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- EXTesia — Curatia Medical Limited · Class IIa
- Introducer Set — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- EXTesia — Curatia Medical Limited · Class IIa
- Shun Guider — Shunmei Medical Co.,Ltd · Class IIa
- PMI — PROGRESSIVE MEDICAL, INC. · Class II
Cleared under the same submission
K071330 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
- VSI — TELEFLEX INCORPORATED
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 a0af1f2e-09f9-4f19-84c5-85f26b3c746a 38 fields · synced May 30, 2026