Model: Elite 200
Catalog: XMD007
DI: 00860011754503
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
Imex Elite 200 Doppler system main unit
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3ef9f548-a7e5-41b0-bce6-b3777686fdc9
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:
00860011754503
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34040
Name: Foetal Doppler system
Definition:
A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.
FDA Product Codes
JAF
Monitor, Ultrasonic, Nonfetal
Premarket Submissions
Submission Number:
K982635
Supplement Number:
000