FDA.reportPublic FDA data

M-Drain

Primary DI
05711055001762
Brand
M-Drain
Company
Mermaid Medical A/S
Model
DS2010100
Catalog number
DS2010100
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 nee
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#

Product Codes#

Code, Name table
CodeName
DREDilator, Vessel, For Percutaneous Catheterization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071330000GALTSTICK INTRODUCER SYSTEMGalt Medical Corp.2007-10-31DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711055001762PackageGS15In Commercial Distribution
15711055001769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711055001762057110550017625711055001762
1571105500176915711055001769

GMDN Terms#

Term, Definition table
TermDefinition
Interventional radiology percutaneous-access procedure kitA collection of various sterile radiopaque instruments/devices (e.g., introducer sheath, dilator, needle, angiographic catheter) intended to be used for image-guided, single-puncture, percutaneous access to facilitate an interventional radiology procedure (e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures). It does not contain pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Device Size Text, specify0
Length20Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight and keep dry
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

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
false
HCT/P
false
Kit
true
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
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
15711055000663M-DrainD10510020D105100202016-09-24
15711055000670M-DrainD10510025D105100252016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450708955Prelude®Merit Medical Systems, Inc.DRE2026-07-18
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00884450860342Merit S-MAK™Merit Medical Systems, Inc.DRE2026-06-25
00884450468340Merit MAK™Merit Medical Systems, Inc.DRE2026-06-23
10884450706708Prelude®Merit Medical Systems, Inc.DRE2026-06-03
10884450415358Prelude®Merit Medical Systems, Inc.DRE2026-05-28
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