Home GUDID 25711055001834
M-Drain
Primary DI 25711055001834
Brand M-Drain
Company Mermaid Medical A/S
Model DS2010400
Catalog number DS2010400
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 needle).
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
Product Codes# Code, Name table Code Name DRE Dilator, Vessel, For Percutaneous Catheterization
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 25711055001834 Package GS1 5 In Commercial Distribution 15711055001837 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 25711055001834 25711055001834 15711055001837 15711055001837
GMDN Terms# Term, Definition table Term Definition Interventional radiology percutaneous-access kit, single-use A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 6 French Device Size Text, specify 0 Length 20 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 Storage Environment Temperature -29 Degrees Celsius 60 Degrees Celsius
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10884450706708 Prelude® Merit Medical Systems, Inc. DRE 2026-06-03 10884450415358 Prelude® Merit Medical Systems, Inc. DRE 2026-05-28 10841156105921 VSI TELEFLEX INCORPORATED DRE 2020-02-06 10841156105945 VSI TELEFLEX INCORPORATED DRE 2020-02-06 10841156105907 VSI TELEFLEX INCORPORATED DRE 2020-01-27 10841156105914 VSI TELEFLEX INCORPORATED DRE 2020-01-27 10841156105938 VSI TELEFLEX INCORPORATED DRE 2020-01-27 10841156105952 VSI TELEFLEX INCORPORATED DRE 2020-01-27 08714729295822 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 08714729295839 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 08714729295853 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 08714729375555 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 08714729742913 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 10827002237374 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002237466 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002237473 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002465395 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002465401 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002465418 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10884450007829 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450007867 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450007904 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008086 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008109 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008147 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008857 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008871 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008888 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008895 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008901 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24