FDA.reportPublic FDA data

M-Drain Centesis Catheter

Primary DI
15711055001981
Brand
M-Drain Centesis Catheter
Company
Mermaid Medical A/S
Model
D40105007
Catalog number
D40105007
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
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05711055001984PackageGS110Not in Commercial Distribution
15711055001981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711055001984057110550019845711055001984
1571105500198115711055001981

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
Length7Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00 Keep away from sunlight and keep dry

Contacts#

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

Regulatory Flags#

DUNS number
308951313
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
15711055000663M-DrainD10510020D105100202016-09-24
15711055000670M-DrainD10510025D105100252016-09-24
15711055000700M-DrainD10512025D105120252016-09-24
15711055000724M-DrainD10514025D105140252016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10810068811060MONARCH™Guided Percutaneous Access KitAuris Health, Inc.GCB2026-05-04
00884450820667MAK-NV™Merit Medical Systems, Inc.GCB2026-02-24
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10381780538493MicroFrance®INTEGRA MICROFRANCEGCB2024-05-29
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10841156110963TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
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20841156110946TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
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