Model: Direct AO cable - Edwards transducer
Catalog: F201320
DI: 07540184013203
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c9fdd192-7b6b-4f73-92de-a5bdb3acaf0b
Distribution Status:
In Commercial Distribution
DUNS Number:
253717946
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07540184013203
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 10980
Name: Cardiac catheterization laboratory computer
Definition:
A dedicated computer designed to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into useful parameters, e.g., cardiac output, pressure gradients, valve areas, shunt flows, vascular resistance, diastolic filling period or systolic ejection period. The computer may store these values chronologically, along with other physiologic events that occur during the procedure. This GMDN code may reflect old technology; its functions may be performed using off-the-shelf computer ware and dedicated software.
FDA Product Codes
DXO
Transducer, Pressure, Catheter Tip
Premarket Submissions
Item #1 - Submission Number:
K202943
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K213854
Item #2 - Supplement Number:
000
Item #3 - Submission Number:
K241418
Item #3 - Supplement Number:
000
Item #4 - Submission Number:
K251367
Item #4 - Supplement Number:
000