AccessGUDID - DEVICE: C3 WAVE SYSTEMC3 WAVE SYSTEM (00884908146905)

GUDID

Device Identifier (DI) Information

Brand Name: C3 WAVE SYSTEMC3 WAVE SYSTEM
Version or Model: DMRC3S915
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DMRC3S915
Company Name: Medical Components, Inc.

Primary DI Number: 00884908146905
Issuing Agency: GS1
Commercial Distribution End Date: January 26, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 038000253 *Terms of Use

Device Description: C3 WAVE CASEC3 WAVE CASE

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?
61564	Central venous catheter navigation system, electrocardiographic	An assembly of noninvasive devices intended to use electrocardiographic (ECG) data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC), central venous catheter (CVC), haemodialysis catheter]. It includes a portable battery-powered control unit, ECG cable(s), and ECG lead(s). The catheter (not included) is used as an intravascular electrode, with the guidewire or intraluminal saline used as a conductor. The control unit processes ECG signals and sends them to a separate off-the-shelf device (e.g., smartphone), whereby intravascular ECG changes indicate catheter position typically in conjunction with skin surface ECG data.	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: 2aadc6d8-a0a2-4761-ab58-d96fe951fcc8
Public Version Date: February 09, 2021
Public Version Number: 2
DI Record Publish Date: August 27, 2019