BREEZE® APD

Basic Information

• Brand Name: BREEZE® APD
• Primary DI: 00884908138702
• Version / Model: BALPN1035S
• Catalog Number: BALPN1035S
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-26
• Public Version: 1
• Public Version Date: 2022-03-07
• Public Version Status: New
• Public Device Record Key: 91013109-3305-4ee5-b87f-8ee1819cdf19

Device Description

10F X 35CM BREEZE® ALL PURPORSE DRAIN WITH LOCKING PIGTAIL SET

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGE	Stents, drains and dilators for the biliary ducts	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30884908138703	GS1	inner box	5	In Commercial Distribution
Primary	00884908138702	GS1
Package	50884908138707	GS1	box	20	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]