Device
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation andpulse rate for use with the finger of adult patients in healthcare environments. And...
Manufacturer
SHENZHEN YIMI LIFE- TECHNOLOGY CO.LTD
SHENZHEN YIMI LIFE- TECHNOLOGY CO.LTD
Model: YM111
DI: 06972911370142
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation andpulse rate for use with the finger of adult patients in healthcare environments. And it is not intendedto be used under motion or low perfusion scenarios.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4d7faa0a-e70b-44db-b557-bbba2db03bcc
Distribution Status:
In Commercial Distribution
DUNS Number:
554452543
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
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:
06972911370142
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45607
Name: Pulse oximeter
Definition:
An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.
FDA Product Codes
DQA
Oximeter
Premarket Submissions
Submission Number:
K240092
Supplement Number:
000