AccessGUDID - DEVICE: Arctic Front Advance Pro™ (00763000245412)

GUDID

Device Identifier (DI) Information

Brand Name: Arctic Front Advance Pro™
Version or Model: AFAPRO23
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000245412
Issuing Agency: GS1
Commercial Distribution End Date: September 27, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: CATH AFAPRO23 AFA PRO 23 US

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:	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?
60720	Cardiac cryosurgical system catheter	A sterile, flexible device intended to be used as part of a cardiac tissue cryosurgical system to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and deliver pressurized liquid refrigerant (e.g., nitrous oxide) to its distal cooling segment to achieve extremely low temperatures through gas expansion; it typically includes sensors (e.g., temperature monitoring). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P100010	093

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: Keep dry
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Handling Environment Temperature: between -31 and 113 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Catheter tip width 23 mm
Length: 95.0 Centimeter
Device Size Text, specify: Catheter shaft size 10.5 Fr

Device Record Status

Public Device Record Key: 1409c88b-e1a9-4137-94d5-4ff22db8b20a
Public Version Date: July 06, 2023
Public Version Number: 2
DI Record Publish Date: October 24, 2019