AccessGUDID - DEVICE: SWAN-GANZ (00690103000221)

GUDID

Device Identifier (DI) Information

Brand Name: SWAN-GANZ
Version or Model: 040F4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 040F4
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103000221
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: NON-BALLOON DUAL LUMEN OXIMETRY 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":	No
For Single-Use:	Yes
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?
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
DQE	CATHETER, OXIMETER, FIBEROPTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K926450	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: 4F (1.33MM), USABLE LENGTH: 40CM, RECOMMENDED GUIDEWIRE SIZE: 0.016 IN (0.41 MM), MINIMUM INTRODUCER SIZE: 4.5F (1.50 MM)

Device Record Status

Public Device Record Key: 6587e6aa-aadd-4292-ac50-643a6c8a2003
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 03, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)822-9637
Email: tech_support@edwards.com

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