FDA UDI In Commercial Distribution 🇺🇸 United States

Current™

DI: 05415067051813 · Model: GEN-3RD-REC · ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Current™
Primary DI
05415067051813
Version / Model
GEN-3RD-REC
Catalog Number
GEN-3RD-REC
Company Name
ST. JUDE MEDICAL, INC.
Labeler DUNS
149818952
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-01-06
Public Version
1
Public Version Date
2026-01-14
Public Version Status
New
Public Device Record Key
11bb54cd-a108-4a11-b25a-a96648e92570

Device Description

PFA Recording System Connect Cable

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
QZI Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

GMDN Terms

Code Name
47487 Electrical-only medical device connection cable, reusable

Identifiers

Type ID
Primary 05415067051813

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
P250022 000

Device Sizes

Type Value Unit Text
Length 406.0000 Centimeter

Storage Conditions

Type
Handling Environment Humidity
Temperature Range
10 – 90 Percent (%) Relative Humidity
Type
Storage Environment Humidity
Temperature Range
10 – 90 Percent (%) Relative Humidity
Type
Handling Environment Temperature
Temperature Range
-25 – 60 Degrees Celsius
Type
Storage Environment Temperature
Temperature Range
-25 – 60 Degrees Celsius