FDA UDI
In Commercial Distribution
🇺🇸 United States
M-Drain Centesis Catheter
DI: 15711055002001
·
Model: D40105015
·
Mermaid Medical A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- M-Drain Centesis Catheter
- Primary DI
- 15711055002001
- Version / Model
- D40105015
- Catalog Number
- D40105015
- Company Name
- Mermaid Medical A/S
- Labeler DUNS
- 308951313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-05
- Public Version
- 2
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- a73d7126-9366-4c15-bbf8-fcd2dd07d620
Device Description
M-Drain Centesis Catheter is used in percutaneous fluid aspirations and small volume drainage procedures.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCB | Needle, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47796 | 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05711055002004 | GS1 | Retail Box | 10 | In Commercial Distribution | |
| Primary | 15711055002001 | GS1 |
Customer Contacts
- Phone
- +4547108570
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 5 | French | |
| Length | 15 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight and keep dry