AccessGUDID - DEVICE: CoolFlow (10846835000085)

GUDID

Device Identifier (DI) Information

Brand Name: CoolFlow
Version or Model: CFP002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CFP002
Company Name: Biosense Webster Inc

Primary DI Number: 10846835000085
Issuing Agency: GS1
Commercial Distribution End Date: August 07, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 020163218 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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?
60784	Cardiac radio-frequency ablation system generator	An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990071	005

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Special Storage Condition, Specify: Do not use if package is damaged
Special Storage Condition, Specify: Do not use if package is opened
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep out of direct sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 606f16b1-b87c-481e-b6b3-80b9197012bf
Public Version Date: August 08, 2023
Public Version Number: 8
DI Record Publish Date: September 10, 2014