SwitchBack™

Basic Information

• Brand Name: SwitchBack™
• Primary DI: 04046964786914
• Version / Model: 622520
• Catalog Number: 622520
• Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC
• Labeler DUNS: 784259751
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-08-30
• Public Version: 8
• Public Version Date: 2022-11-02
• Public Version Status: Update
• Public Device Record Key: 6e98d80e-4382-46ea-be9d-5a0c36f25c7e

Device Description

14CC-55ATM INFLATION DEVICE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
KOE	DILATOR, URETHRAL	Gastroenterology, Urology	876.5520	2
MAV	Syringe, balloon inflation	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17541	Catheter/overtube balloon inflator, single-use	A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964786914	GS1
Unit of Use	04046964786907	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Capacity (ml) : 14.000 ML