AccessGUDID - DEVICE: PowerPICC SOLO2 HF Catheter with Sherlock Tip Location System (TLS) Stylet (00801741035890)

GUDID

Device Identifier (DI) Information

Brand Name: PowerPICC SOLO2 HF Catheter with Sherlock Tip Location System (TLS) Stylet
Version or Model: 9395108Q
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9395108Q
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741035890
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: PowerPICC SOLO HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
36257	Peripherally-inserted central venous catheter	A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.	Active	true

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 5 French
Length: 55 Centimeter

Device Record Status

Public Device Record Key: 668ea96f-ac94-4810-a06c-a7ccd907fcae
Public Version Date: February 19, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2015