AccessGUDID - DEVICE: PRESEP (00690103176810)

GUDID

Device Identifier (DI) Information

Brand Name: PRESEP
Version or Model: X3816S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: X3816S
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103176810
Issuing Agency: GS1
Commercial Distribution End Date: November 13, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: PRESEP OXIMETRY CATHETER 8.5F 16CM W/O THROMBOSHIELD

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
DQE	CATHETER, OXIMETER, FIBEROPTIC
DRE	DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053609	000
K110167	000

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 A COOL, DRY PLACE.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Exterior Diameter: 8.5 F (2.8 mm), Usable Length: 16 cm, Number of Lumens: 3, Recommended Guidewire Size: 0.032" (0.81 mm)

Device Record Status

Public Device Record Key: c74e2d75-cbe4-4c61-9361-c92c7d016c3e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 03, 2016