AccessGUDID - DEVICE: M-Drain (15711055000397)

GUDID

Device Identifier (DI) Information

Brand Name: M-Drain
Version or Model: D14008040
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D14008040
Company Name: Mermaid Medical A/S

Primary DI Number: 15711055000397
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308951313 *Terms of Use

Device Description: The catheter is designed for percutaneous biliary drainage. The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These kits are classified according to the catheter size (8F~14F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either D140 or D145 (with or without locking pigtail).

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:	No
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?
10696	Biliary drain	A flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FGE	Catheter, Biliary, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033862	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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Biliary
Length: 40 Centimeter
Catheter Gauge: 8 French

Device Record Status

Public Device Record Key: dc19c16f-e3eb-417e-82b8-c02237f21964
Public Version Date: November 19, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2016