Sherlock 3CG+ TCS System Version 3.2.0 Sherlock 3CG+ TCS Software Version 3.2.0

GUDID 00801741223129

CVAD Tip Confirmation System

Bard Access Systems, Inc.

Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic Central venous catheter navigation system, electrocardiographic/magnetic
Primary Device ID00801741223129
NIH Device Record Keyb0399612-356e-4b3b-864f-ea35d5f858de
Commercial Distribution StatusIn Commercial Distribution
Brand NameSherlock 3CG+ TCS System Version 3.2.0
Version Model NumberSherlock 3CG+ TCS Software Version 3.2.0
Catalog NumberSherlock 3CG+ TCS Software Version 3.2.0
Company DUNS044611812
Company NameBard Access Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741223129 [Primary]

FDA Product Code

LJSCatheter, intravascular, therapeutic, long-term greater than 30 days

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-21
Device Publish Date2022-01-13

Devices Manufactured by Bard Access Systems, Inc.

00801741219214 - Sherlock 3CG+, BD SiteRite 9 Ultrasound System2024-03-27 SiteRite 9 Sherlock Software
00801741227707 - BD SiteRite 9 Ultrasound System2024-03-27 BD SiteRite 9 Ultrasound System (Refurbished)
00801741231124 - Sherlock 3CG+, BD SiteRite 9 Ultrasound System2024-03-27 Site~Rite 9 Ultrasound Software
10801741231251 - PowerPICC2024-03-25 Catheter Placement Kit
00801741000270 - STATLOCK2023-12-21 StatLock™ Stabilization Device(IV Ultra)
00801741081507 - STATLOCK2023-12-21 StatLock™ Stabilization Device (CV Plus, Crescent Tricot Pad, Sliding Post Retainer)
00801741081538 - STATLOCK2023-12-21 StatLock® Stabilization Device (CV Plus,Butterfly Tricot Pad,Sliding Post Retainer)
00801741081637 - STATLOCK2023-12-21 StatLock® Stablization Device(Dialysis, Butterfly Tricot Pad, Clamshell Retainer)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.