AccessGUDID - DEVICE: Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable (00195451000355)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00195451000355
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055514478 *Terms of Use

Device Description: The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic arteries.

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:	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?
66730	Intravascular lithotripsy system generator	An electrically-powered device intended to produce electrical current for transmission to an appropriate catheter (not included) to perform intravascular lithotripsy in peripheral and/or coronary arteries. It typically includes controls, display, and connection cables. 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 [?]
K221041	000
P200039	006
P200039	007

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
Storage Environment Temperature: between -20 and 65 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5c297e9e-f83c-49d1-b1a4-44d5e4939e82
Public Version Date: April 05, 2023
Public Version Number: 2
DI Record Publish Date: December 22, 2022