B.BRAUN

Basic Information

• Brand Name: B.BRAUN
• Primary DI: 04046955696277
• Version / Model: 350-8600
• Catalog Number: 350-8600
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2021-05-15
• Public Version: 1
• Public Version Date: 2021-05-24
• Public Version Status: New
• Public Device Record Key: 9006432e-ea9a-4528-ad7e-7a2e883d6f50

Device Description

MENTOR TISSUE EXPANDER FILL KIT

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: No
• 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
LCJ	Expander, skin, inflatable	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
59036	Tissue expander injection port	A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids (e.g., saline) typically over multiple expansion sessions. It consists of an auto-sealing port for needle puncture and a tube connector for attachment to the tissue expander. It is available in a variety of designs. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04046955696284	GS1	Carton	6	In Commercial Distribution
Primary	04046955696277	GS1
Unit of Use	04046955696260	GS1

Customer Contacts

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