M-Drain
- Primary DI
- 25711055120047
- Brand
- M-Drain
- Company
- Mermaid Medical A/S
- Model
- D12012040
- Catalog number
- D12012040
- Device 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."
- Published
- 2024-01-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
mermaidmedical.comProduct Codes#
| Code | Name |
|---|---|
| FGE | Catheter, Biliary, Diagnostic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K033862 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 25711055120047 | Package | GS1 | 5 | In Commercial Distribution |
| 15711055120040 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 25711055120047 | 25711055120047 |
| 15711055120040 | 15711055120040 |
GMDN Terms#
| Term | Definition |
|---|---|
| Multi-purpose percutaneous abdominothoracic drainage catheter | A flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. Disposable devices dedicated to catheter introduction may be included with the device. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 5 | French |
| Device Size Text, specify | 0 | |
| Length | 15 | Centimeter |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Keep away from sunlight and keep dry |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +4547108570 | customer@mermaidmedical.com |
Regulatory Flags#
- DUNS number
- 308951313
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 15711055000311 | M-Drain | D13006015 | D13006015 | 2016-09-24 |
| 15711055000328 | M-Drain | D13006020 | D13006020 | 2016-09-24 |
| 15711055000359 | M-Drain | D13008025 | D13008025 | 2016-09-24 |
| 15711055000373 | M-Drain | D13010025 | D13010025 | 2016-09-24 |
| 15711055000410 | M-Drain | D14010040 | D14010040 | 2016-09-24 |
| 15711055000434 | M-Drain | D14012040 | D14012040 | 2016-09-24 |
| 15711055000458 | M-Drain | D14014040 | D14014040 | 2016-09-24 |
| 15711055000472 | M-Drain | D14508040 | D14508040 | 2016-09-24 |
| 15711055000496 | M-Drain | D14510040 | D14510040 | 2016-09-24 |
| 15711055000519 | M-Drain | D14512040 | D14512040 | 2016-09-24 |
| 15711055000533 | M-Drain | D14514040 | D14514040 | 2016-09-24 |
| 15711055000557 | M-Drain | D10506025 | D10506025 | 2016-09-24 |
| 15711055000588 | M-Drain | D10507020 | D10507020 | 2016-09-24 |
| 15711055000595 | M-Drain | D10507025 | D10507025 | 2016-09-24 |
| 15711055000625 | M-Drain | D10508020 | D10508020 | 2016-09-24 |
| 15711055000632 | M-Drain | D10508025 | D10508025 | 2016-09-24 |
| 15711055000663 | M-Drain | D10510020 | D10510020 | 2016-09-24 |
| 15711055000670 | M-Drain | D10510025 | D10510025 | 2016-09-24 |
| 15711055000700 | M-Drain | D10512025 | D10512025 | 2016-09-24 |
| 15711055000724 | M-Drain | D10514025 | D10514025 | 2016-09-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 15711055100400 | M-Drain | Mermaid Medical A/S | FGE | 2024-10-01 |
| 15711055110041 | M-Drain | Mermaid Medical A/S | FGE | 2024-07-20 |
| 15711055110409 | M-Drain | Mermaid Medical A/S | FGE | 2024-07-20 |
| 15711055120040 | M-Drain | Mermaid Medical A/S | FGE | 2024-01-31 |
| 15711055120453 | M-Drain | Mermaid Medical A/S | FGE | 2024-01-31 |
| 15711055000311 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000328 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000359 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000373 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000410 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000434 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000458 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000472 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000496 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000519 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000533 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000557 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000588 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000595 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000625 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000632 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000663 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000670 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000700 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000724 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000748 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000762 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000779 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000809 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000816 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |