M-Drain

Basic Information

• Brand Name: M-Drain
• Primary DI: 15711055000397
• Version / Model: D14008040
• Catalog Number: D14008040
• 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: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: dc19c16f-e3eb-417e-82b8-c02237f21964

Device Description

The catheter is designed for percutaneous biliary drainage. 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 (8F~14F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either D140 or D145 (with or without locking pigtail).

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
FGE	Catheter, Biliary, Diagnostic	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10696	Biliary drain	A flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05711055000390	GS1	Retail box	5	In Commercial Distribution
Primary	15711055000397	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033862	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Biliary
Length	40	Centimeter
Catheter Gauge	8	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight and keep dry