AccessGUDID - DEVICE: Fortify Assura™ (05414734508094)

GUDID

Device Identifier (DI) Information

Brand Name: Fortify Assura™
Version or Model: CD2357-40Q
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CD2357-40Q
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734508094
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: Tiered-therapy cardioverter/defibrillator VVEV VVIR

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
37265	Dual-chamber implantable defibrillator	A battery-powered, hermetically-sealed pulse generator with a cardiac rhythm recognition system intended to collect and analyse electrocardiogram (ECG) data and deliver appropriate electrical impulses to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and to pace the heart (to treat bradycardia). It is implanted in a pouch beneath the skin of the patient's chest or abdomen and intended to be used with leads that are positioned inside the right atrium and right ventricle to monitor the ECG and to automatically deliver the electrical impulse; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NVZ	Pulse generator, permanent, implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: exactly 22 Degrees Celsius
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Special Storage Condition, Specify: Storage excursions permitted from 59°- 86° F (15°- 30°C). Store the device away from magnets and sources of electromagnetic interference.
Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Temperature: exactly 72 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 35 Milliliter

Device Record Status

Public Device Record Key: bca9e7f4-a6ed-4bed-b0ac-bb98f9375414
Public Version Date: February 23, 2022
Public Version Number: 9
DI Record Publish Date: February 03, 2017