SwitchBack™ 622520

GUDID 04046964786914

14CC-55ATM INFLATION DEVICE

B BRAUN INTERVENTIONAL SYSTEMS, INC

Catheter-balloon inflator, single-use
Primary Device ID04046964786914
NIH Device Record Key6e98d80e-4382-46ea-be9d-5a0c36f25c7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSwitchBack™
Version Model Number622520
Catalog Number622520
Company DUNS784259751
Company NameB BRAUN INTERVENTIONAL SYSTEMS, INC
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)836-2228
Email[email protected]

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104046964786907 [Unit of Use]
GS104046964786914 [Primary]

FDA Product Code

KOEDILATOR, URETHRAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-25
Device Publish Date2016-08-30

On-Brand Devices [SwitchBack™]

0404696478691414CC-55ATM INFLATION DEVICE
0404696477314360CC-15ATM INFLATION DEVICE
0404696477312925CC-40ATM INFLATION DEVICE

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.