Model: T200
Catalog: T200
DI: 00850067960041
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
Imex 2MHZ Doppler Probe PD2/CT+
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2e80d49a-243e-4fcd-9e82-e8ac92ab5c45
Distribution Status:
In Commercial Distribution
DUNS Number:
119901967
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850067960041
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41917
Name: Foetal Doppler system probe
Definition:
A hand-operated component of a foetal Doppler system intended to be placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device.
FDA Product Codes
KNG
Monitor, Ultrasonic, Fetal
Premarket Submissions
Submission Number:
K901593
Supplement Number:
000