AccessGUDID - DEVICE: Shockwave Intravascular Lithotripsy (IVL) Connector Cable (00195451000300)

GUDID

Device Identifier (DI) Information

Brand Name: Shockwave Intravascular Lithotripsy (IVL) Connector Cable
Version or Model: 825DP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IVLCC
Company Name: Shockwave Medical, Inc.

Primary DI Number: 00195451000300
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055514478 *Terms of Use
Previous DI: M732IVLCC0

Device Description: The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and is used to activate lithotripsy energy within the IVL balloon catheter.

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?
66727	Electrical catheter connection cable/switch	A non-patient-contact, electrical cord with a connector at both ends and a hand-switch designed to transmit electrical energy from a power supply (e.g., generator) to an electrical catheter (e.g., ultrasonic atherectomy system catheter), and activate/deactivate the electrical supply to the catheter; the power supply and catheter are not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPN	Percutaneous Catheter, Ultrasound
QMG	Shockwave Intravascular Lithotripsy System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191840	000
P200039	000

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: 421d8bdf-9e78-47c3-b2b9-fb74f6e34e50
Public Version Date: April 05, 2023
Public Version Number: 4
DI Record Publish Date: February 11, 2021