FDA UDI In Commercial Distribution 🇺🇸 United States

Adapter cables unipolar/ bipolar (set of 10)

DI: 04260441450482 · Model: 03UBC02 · CardioTek B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Adapter cables unipolar/ bipolar (set of 10)
Primary DI
04260441450482
Version / Model
03UBC02
Company Name
CardioTek B.V.
Labeler DUNS
415868731
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-02-17
Public Version
1
Public Version Date
2020-02-25
Public Version Status
New
Public Device Record Key
c5eb7550-142a-471e-9218-d26dfabdd0ab

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DQK Computer, Diagnostic, Programmable

GMDN Terms

Code Name
17898 Cardiac electrophysiology analysis system

Identifiers

Type ID
Primary 04260441450482

Premarket Submissions

Submission Number Supplement Number
K183266 000