AccessGUDID - DEVICE: SWAN-GANZ (00690103003109)

GUDID

Device Identifier (DI) Information

Brand Name: SWAN-GANZ
Version or Model: 116F4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 116F4
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103003109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: SG PEDIATRIC MONITOR CATH 4F 60CM, FLOW DIRECTED, DBL LUM.

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
DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC
KRA	Catheter, continuous flush

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: 4F (1.33MM), USABLE LENGTH: 60 CM, RECOMMENDED GUIDEWIRE SIZE: 0.018 IN (0.46 MM), MINIMUM INTRODUCER SIZE: 5F (1.67 MM)

Device Record Status

Public Device Record Key: 946aec44-f52a-4235-93d0-82e1c0b85705
Public Version Date: December 04, 2023
Public Version Number: 6
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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