AccessGUDID - DEVICE: EDWARDS OXIMETRY CENTRAL VENOUS CATHETER (00690103197594)

GUDID

Device Identifier (DI) Information

Brand Name: EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
Version or Model: X3816ST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X3816ST
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103197594
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
31659	Oximeter catheter, single-use	A flexible tube containing a fibreoptic bundle designed to conduct light at a selected wavelength through blood to detect the reflected or scattered light for the estimation of blood oxygen concentration. It detects with a sensor at its distal end and is used in conjunction with an oximeter for oxygen concentration calculation. This device is also known as a Swan-Ganz catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXG	COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
DRE	DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
DQE	CATHETER, OXIMETER, FIBEROPTIC

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
Special Storage Condition, Specify: STORE IN COOL, DRY PLACE

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: USABLE LENGTH: 16CM, EXTERIOR DIAMETER: 8.5F (2.8MM), RECOMMENDED GUIDEWIRE SIZE: 0.032 IN (0.81MM)

Device Record Status

Public Device Record Key: 6fe20690-31d7-47c1-aeb1-4108fe207711
Public Version Date: September 28, 2022
Public Version Number: 4
DI Record Publish Date: September 03, 2016