M-Drain DS2010100

GUDID 05711055001762

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 ID05711055001762
NIH Device Record Key5cff59b2-4213-4588-81c3-63e939c34c56
Commercial Distribution StatusIn Commercial Distribution
Brand NameM-Drain
Version Model NumberDS2010100
Catalog NumberDS2010100
Company DUNS308951313
Company NameMermaid Medical A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com

Device Dimensions

Device Size Text, specify0
Length20 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length20 Centimeter
Catheter Gauge6 French
Device Size Text, specify0
Length20 Centimeter
Catheter Gauge6 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105711055001762 [Package]
Contains: 15711055001769
Package: Retail box [5 Units]
In Commercial Distribution
GS115711055001769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DREDilator, Vessel, For Percutaneous Catheterization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [M-Drain]

05711055003018The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055003001The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002998The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002981The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002974The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002912The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002905The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002899The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002882The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002875The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002868The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002851The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002844The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002837The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002820The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002813The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002806The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002790The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002783The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002776The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002769The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002752The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002745The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002738The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002721The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002714The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002707The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002684The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002127The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002110The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002097The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002080The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002073The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002066The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002059The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055002042The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055001946The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleur
05711055001892The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w
05711055001885The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w
05711055001878The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w
05711055001861The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w
05711055001854The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w
05711055001847The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w
05711055001830The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w
05711055001823The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w
05711055001816The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w
05711055001809The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w
05711055001793The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w
05711055001762The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire w
05711055001205The 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
M-DRAIN
79176795 5051833 Live/Registered
Mermaid Medical A/S
2015-09-28

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