FDA.reportPublic FDA data

M-Drain Centesis Catheter

Primary DI
05711055002011
Brand
M-Drain Centesis Catheter
Company
Mermaid Medical A/S
Model
D40105020
Catalog number
D40105020
Device description
M-Drain Centesis Catheter is used in percutaneous fluid aspirations and small volume drainage procedures.
Published
2019-08-05
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#

Product Codes#

Code, Name table
CodeName
GCBNeedle, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCBNeedle, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711055002011PackageGS110In Commercial Distribution
15711055002018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711055002011057110550020115711055002011
1571105500201815711055002018

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose percutaneous abdominothoracic drainage catheterA flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. Disposable devices dedicated to catheter introduction may be included with the device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French
Length20Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight and keep dry

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
308951313
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
15711055003237M-DrainD11012030SD11012030S2026-09-04
15711055003244M-DrainD11014030SD11014030S2026-09-04
15711055005125Drain-LokA301005122026-07-08
15711055012185Drain-LokA301012182026-07-08
15711055000311M-DrainD13006015D130060152016-09-24
15711055000328M-DrainD13006020D130060202016-09-24
15711055000359M-DrainD13008025D130080252016-09-24
15711055000373M-DrainD13010025D130100252016-09-24
15711055000410M-DrainD14010040D140100402016-09-24
15711055000434M-DrainD14012040D140120402016-09-24
15711055000458M-DrainD14014040D140140402016-09-24
15711055000472M-DrainD14508040D145080402016-09-24
15711055000496M-DrainD14510040D145100402016-09-24
15711055000519M-DrainD14512040D145120402016-09-24
15711055000533M-DrainD14514040D145140402016-09-24
15711055000557M-DrainD10506025D105060252016-09-24
15711055000588M-DrainD10507020D105070202016-09-24
15711055000595M-DrainD10507025D105070252016-09-24
15711055000625M-DrainD10508020D105080202016-09-24
15711055000632M-DrainD10508025D105080252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068811084MONARCH™ Kit Catheter & AccessoriesAuris Health, Inc.GCB2026-05-05
10810068811060MONARCH™Guided Percutaneous Access KitAuris Health, Inc.GCB2026-05-04
00884450820667MAK-NV™Merit Medical Systems, Inc.GCB2026-02-24
00661392008960LSL HEALTHCARELSL Industries, LLCGCB2025-10-30
10841156111830TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111847TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111854TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111861TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111837TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111844TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111851TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111868TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
14026704920263PILLINGTELEFLEX INCORPORATEDGCB2024-07-15
14026704920270PILLINGTELEFLEX INCORPORATEDGCB2024-07-15
00884450820643MAK-NV™Merit Medical Systems, Inc.GCB2024-06-28
10884450820640MAK-NV™Merit Medical Systems, Inc.GCB2024-06-28
00884450820568MAK-NV™Merit Medical Systems, Inc.GCB2024-06-18
10884450820565MAK-NV™Merit Medical Systems, Inc.GCB2024-06-18
00884450820612MAK-NV™Merit Medical Systems, Inc.GCB2024-06-15
10884450820619MAK-NV™Merit Medical Systems, Inc.GCB2024-06-15
00884450820636MAK-NV™Merit Medical Systems, Inc.GCB2024-06-12
10884450820633MAK-NV™Merit Medical Systems, Inc.GCB2024-06-12
10381780538493MicroFrance®INTEGRA MICROFRANCEGCB2024-05-29
10841156110949TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110956TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110963TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110970TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110946TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110953TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110960TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08