AccessGUDID - DEVICE: Merit Medical® (00884450015285)

GUDID

Device Identifier (DI) Information

Brand Name: Merit Medical®
Version or Model: 00884450015285
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PC201/B
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 00884450015285
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184763290 *Terms of Use

Device Description: No description.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
10741	Pericardiocentesis catheter	A flexible tube designed for the drainage of effusion from the pericardial sac (the pericardium). It typically consists of a thin walled, flexible, plastic [e.g., polyethylene (PE)] tube with a J-shaped distal tip perforated with multiple holes in both its convex and concave sides. It is introduced percutaneously into the pericardium, anchored in place, and connected to a water-seal drainage system. It can be left in situ for some days or weeks during the treatment of cardiac tamponade and can be used for the irrigation/instillation of drugs (e.g., antibiotics, cytotoxic agents) into the pericardium. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBX	CATHETER, IRRIGATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 611ad5a6-c1b8-4c11-9bfa-9e6d1774beeb
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: February 16, 2018