Device
Biolight Compatible Direct-Connect SpO2 Sensor, Pediatric Soft
Manufacturer
APK Technology Co.,Ltd.
APK Technology Co.,Ltd.
Model: S110S-68D0
DI: 06946725558331
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Biolight Compatible Direct-Connect SpO2 Sensor, Pediatric Soft
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bf2df12f-87ce-42c9-b9af-490726888a68
Distribution Status:
In Commercial Distribution
DUNS Number:
529691989
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06946725558331
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37808
Name: Pulse oximeter probe, reusable
Definition:
A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.
FDA Product Codes
DQA
Oximeter
Premarket Submissions
Submission Number:
K082846
Supplement Number:
000