DEVICE: SwitchBack™ (04046964786914)

Download: XML | JSON

Device Identifier (DI) Information

SwitchBack™
622520
622520
B BRAUN INTERVENTIONAL SYSTEMS, INC
04046964786914
GS1
10
14CC-55ATM INFLATION DEVICE
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Catheter-balloon inflator, single-use A sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., 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 syringe/plunger mechanism, a gauge or integral pressure transducer for monitoring pressure within the balloon, a locking mechanism, and a connecting tube. It may also be used to inflate the balloon of an inflatable balloon tamp or an endomicroscopy probe. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KOE DILATOR, URETHRAL
MAV Syringe, balloon inflation
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Capacity (ml) : 14.000 ML
CLOSE

Device Status

In Commercial Distribution
August 30, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 04046964786907 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
CLOSE