Model: 1573972
Catalog: 1573972
DI: 07340201503737
Status: New
MRI: MR Conditional
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
VISUAL GUIDANCE
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
272838f7-2a1f-491c-8d29-f6631699132a
Distribution Status:
In Commercial Distribution
DUNS Number:
353272181
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07340201503737
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 56623
Name: Breath-hold system remote display
Definition:
A non-sterile, battery-powered component of a breath-hold system designed as the patient interface display, via a system of indicators [e.g., light-emitting diodes (LEDs)], to instruct the patient when and how long to hold their breath for scheduled breath holds. It receives wirelessly the electronic bio-feedback sequences from the system's base station and is situated in the viewing line of the patient. This is a reusable device.
FDA Product Codes
IYE
Accelerator, linear, medical