AccessGUDID - DEVICE: M-Drain (15711055001844)

GUDID

Device Identifier (DI) Information

Brand Name: M-Drain
Version or Model: DS2010500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DS2010500
Company Name: Mermaid Medical A/S

Primary DI Number: 15711055001844
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308951313 *Terms of Use

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).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60437	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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DRE	Dilator, Vessel, For Percutaneous Catheterization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071330	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight and keep dry
Storage Environment Temperature: between -29 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit
Length: 20 Centimeter
Catheter Gauge: 6 French

Device Record Status

Public Device Record Key: 3348879f-9b7b-487c-b9fc-c2b132f8be7a
Public Version Date: October 10, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016