AccessGUDID - DEVICE: FlexAbility™ (05415067020093)

GUDID

Device Identifier (DI) Information

Brand Name: FlexAbility™
Version or Model: A-FASE-JJ
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A-FASE-JJ
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067020093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: Ablation Catheter

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
61785	Cardiac radio-frequency ablation system catheter	A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P110016	025
P110016	043
P110016	045
P110016	072
P110016	080

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, dark, dry place.
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Humidity: between 25 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 25 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 8 French

Device Record Status

Public Device Record Key: 97e394a2-76aa-45c9-9589-c282944b27da
Public Version Date: February 22, 2023
Public Version Number: 5
DI Record Publish Date: February 22, 2017

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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