M-Drain

Basic Information

• Brand Name: M-Drain
• Primary DI: 15711055001806
• Version / Model: D20206020
• Catalog Number: D20206020
• Company Name: Mermaid Medical A/S
• Labeler DUNS: 308951313
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-10-10
• Public Version Status: Update
• Public Device Record Key: a135611d-723a-4d4a-8d0c-da336e41aa9c

Device 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).

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: No
• 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
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	870.1310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60437	Interventional radiology percutaneous-access kit, single-use	A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05711055001809	GS1	Retail box	5	In Commercial Distribution
Primary	15711055001806	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K071330	000

Device Sizes

Type	Value	Unit	Text
Length	20	Centimeter
Catheter Gauge	6	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight and keep dry
• Type: Storage Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius