AccessGUDID - DEVICE: BREEZE® BILIARY DRAINAGE CATHETER (00884908148022)

GUDID

Device Identifier (DI) Information

Brand Name: BREEZE® BILIARY DRAINAGE CATHETER
Version or Model: BBNPW1040S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BBNPW1040S
Company Name: Medical Components, Inc.

Primary DI Number: 00884908148022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038000253 *Terms of Use

Device Description: 10F X 40CM BREEZE® BILIARY DRAIN WITHOUT LOCKING PIGTAIL SET

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?
32337	Abdominal paracentesis needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument used to perform therapeutic or diagnostic aspiration of fluids/air from the abdominal cavity. It may be used for the placement/operation of a paracentesis catheter or used directly without a catheter. It is typically made of high-grade stainless steel and may have an attached stopcock to control the aspiration process. The device is commonly used to remove ascites fluid from the peritoneal cavity. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGE	Stents, Drains And Dilators For The Biliary Ducts

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210419	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 95d447b3-5e99-417d-89e5-d679a980218b
Public Version Date: February 06, 2023
Public Version Number: 1
DI Record Publish Date: January 29, 2023