AccessGUDID - DEVICE: Site~Rite 8 (00801741219436)

GUDID

Device Identifier (DI) Information

Brand Name: Site~Rite 8
Version or Model: Sherlockv3.1.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Sherlockv3.1.1
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741219436
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: Site~Rite 8 Sherlock Application Software

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61667	Central venous catheter navigation system, electrocardiographic/magnetic	An assembly of devices intended to use electrocardiographic (ECG) and magnetic data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC)]. It includes a mains electricity (AC-powered) control unit [with internal rechargeable batteries] and visual display, ECG skin electrodes, lead(s) and cable(s), a magnetic sensor to be placed on the patient’s chest, and a remote control. The system is designed to be used with a dedicated catheter/stylet (not included) which functions as an intravascular ECG electrode and magnet whose position is detected by the sensor.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d9971cfb-379c-4318-918f-1bfc37f4aa51
Public Version Date: March 01, 2021
Public Version Number: 1
DI Record Publish Date: February 19, 2021