M-Drain DS2010200
GUDID 05711055001816
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 nee
Mermaid Medical A/S
Interventional radiology percutaneous-access procedure kit| Primary Device ID | 05711055001816 |
| NIH Device Record Key | 00c5404d-f73d-4153-840f-d80ee46273ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M-Drain |
| Version Model Number | DS2010200 |
| Catalog Number | DS2010200 |
| Company DUNS | 308951313 |
| Company Name | Mermaid Medical A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +4547108570 |
| customer@mermaidmedical.com | |
| Phone | +4547108570 |
| customer@mermaidmedical.com | |
| Phone | +4547108570 |
| customer@mermaidmedical.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 20 Centimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 20 Centimeter |
| Catheter Gauge | 6 French |
| Device Size Text, specify | 0 |
| Length | 20 Centimeter |
| Catheter Gauge | 6 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and keep dry |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and keep dry |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight and keep dry |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05711055001816 [Package] Contains: 15711055001813 Package: Retail box [5 Units] In Commercial Distribution |
| GS1 | 15711055001813 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071330
FDA Product Code
| DRE | Dilator, Vessel, For Percutaneous Catheterization |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [M-Drain]
| 05711055003018 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055003001 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002998 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002981 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002974 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002912 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002905 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002899 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002882 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002875 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002868 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002851 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002844 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002837 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002820 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002813 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002806 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002790 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002783 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002776 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002769 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002752 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002745 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002738 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002721 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002714 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002707 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002684 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002127 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002110 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002097 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002080 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002073 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002066 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002059 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055002042 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055001946 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
| 05711055001892 | The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w |
| 05711055001885 | The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w |
| 05711055001878 | The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w |
| 05711055001861 | The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w |
| 05711055001854 | The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w |
| 05711055001847 | The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w |
| 05711055001830 | The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w |
| 05711055001823 | The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w |
| 05711055001816 | The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w |
| 05711055001809 | The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w |
| 05711055001793 | The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w |
| 05711055001762 | The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w |
| 05711055001205 | The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur |
Trademark Results [M-Drain]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 M-DRAIN 79176795 5051833 Live/Registered |
Mermaid Medical A/S 2015-09-28 |
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