AccessGUDID - DEVICE: SWAN-GANZ TRUE SIZE (00690103017236)

GUDID

Device Identifier (DI) Information

Brand Name: SWAN-GANZ TRUE SIZE
Version or Model: S111F7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S111F7
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103017236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: SWAN-GANZ TRUE SIZE MONITORING "S" TIP 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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
34925	Pulmonary artery balloon catheter, electrical	A flexible tube with an inflatable balloon(s) and electrical component(s) [e.g., thermistor, fibreoptic bundle] at its distal tip designed to be introduced percutaneously into the venous system via a central vein, and advanced to the pulmonary artery, to measure/monitor haematological parameters [e.g., pulmonary arterial pressures (e.g., wedge), cardiac output, cardiac index, mixed venous oxygen saturation (SvO2)]; it might use thermal dilution techniques and in addition be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYG	CATHETER, FLOW DIRECTED
DQE	CATHETER, OXIMETER, FIBEROPTIC
KRA	Catheter, continuous flush
DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160084	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: 7 F (2.3MM), USABLE LENGTH: 110 CM, RECOMMENDED GUIDEWIRE SIZE: 0.038 IN (0.97 MM), MINIMUM INTRODUCER SIZE: 8 F (2.7 MM)

Device Record Status

Public Device Record Key: 13b4e4be-345c-4df1-a0e4-ed9abd5659cc
Public Version Date: December 04, 2023
Public Version Number: 6
DI Record Publish Date: September 03, 2016