AccessGUDID - DEVICE: PowerLine (00801741036613)

GUDID

Device Identifier (DI) Information

Brand Name: PowerLine
Version or Model: 0720515
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0720515
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741036613
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: PowerLine Central Venous Catheter. 5F Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff. Microintroducer Kit

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:	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?
10729	Centrally-inserted central venous catheter	A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 50 Centimeter
Catheter Gauge: 5 French

Device Record Status

Public Device Record Key: 9ea67f44-5a67-43ba-8cdb-bd2d26640786
Public Version Date: August 28, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2015