M-Drain

Primary DI: 05711055000536
Brand: M-Drain
Company: Mermaid Medical A/S
Model: D14514040
Catalog number: D14514040
Device description: The catheter is designed for percutaneous biliary drainage. The operator can use different drainage sets according to the type of accumulated fluid an
Published: 2016-09-24
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: true
Single use: true

Contact Domains#

mermaidmedical.com

Product Codes#

Code, Name table
Code	Name
FGE	Catheter, Biliary, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K033862	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K033862	000	BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK	Bioteque Corp.	2005-02-14	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
05711055000536	Package	GS1	5	In Commercial Distribution
15711055000533	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
05711055000536	05711055000536	5711055000536
15711055000533	15711055000533

GMDN Terms#

Term, Definition table
Term	Definition
Biliary drainage catheter	A flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
Type	Value	Unit
Catheter Gauge	14	French
Device Size Text, specify	0
Length	40	Centimeter

Storage And Handling#

Type, Low, High table
Type	Low	High	Condition
Special Storage Condition, Specify	0	0	Keep away from sunlight and keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
Phone	Email
+4547108570	customer@mermaidmedical.com

Regulatory Flags#

DUNS number: 308951313
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: false
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: true
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: true
Sterilization required before use: false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
15711055000311	M-Drain	D13006015	D13006015	2016-09-24
15711055000328	M-Drain	D13006020	D13006020	2016-09-24
15711055000359	M-Drain	D13008025	D13008025	2016-09-24
15711055000373	M-Drain	D13010025	D13010025	2016-09-24
15711055000410	M-Drain	D14010040	D14010040	2016-09-24
15711055000434	M-Drain	D14012040	D14012040	2016-09-24
15711055000458	M-Drain	D14014040	D14014040	2016-09-24
15711055000472	M-Drain	D14508040	D14508040	2016-09-24
15711055000496	M-Drain	D14510040	D14510040	2016-09-24
15711055000519	M-Drain	D14512040	D14512040	2016-09-24
15711055000533	M-Drain	D14514040	D14514040	2016-09-24
15711055000557	M-Drain	D10506025	D10506025	2016-09-24
15711055000588	M-Drain	D10507020	D10507020	2016-09-24
15711055000595	M-Drain	D10507025	D10507025	2016-09-24
15711055000625	M-Drain	D10508020	D10508020	2016-09-24
15711055000632	M-Drain	D10508025	D10508025	2016-09-24
15711055000663	M-Drain	D10510020	D10510020	2016-09-24
15711055000670	M-Drain	D10510025	D10510025	2016-09-24
15711055000700	M-Drain	D10512025	D10512025	2016-09-24
15711055000724	M-Drain	D10514025	D10514025	2016-09-24

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
15711055100400	M-Drain	Mermaid Medical A/S	FGE	2024-10-01
15711055110041	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055110409	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055120040	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055120453	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055000311	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000328	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000359	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000373	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000410	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000434	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000458	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000472	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000496	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000519	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000533	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000557	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000588	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000595	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000625	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000632	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000663	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000670	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000700	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000724	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000748	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000762	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000779	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000809	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000816	M-Drain	Mermaid Medical A/S	FGE	2016-09-24

M-Drain

Related Records#

Contact Domains#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

Alternate GTIN / UPC / EAN Codes

GMDN Terms#

Device Sizes#

Storage And Handling#

Sterilization Methods#

Contacts#

Regulatory Flags#

Other Devices From This Company#

Other Devices Sharing Product Codes#