NA

Basic Information

• Brand Name: NA
• Primary DI: 10841983102667
• Version / Model: TL-052S
• Catalog Number: TL-052S
• Company Name: NIHON KOHDEN AMERICA, INC.
• Labeler DUNS: 021063219
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 38d7350e-53d2-4c6a-8e33-c71e1f391ee2

Device Description

SpO2 probe Adults, child (from 15 to 50 kg) Finger, disposable

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRT	MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)	Cardiovascular	870.2300	2
MWI	MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.2300	2
OLV	Standard polysomnograph with electroencephalograph	Neurology	882.1400	2
GWQ	Full-montage Standard Electroencephalograph	Neurology	882.1400	2
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE	Neurology	882.1870	2
OLT	Non-normalizing quantitative electroencephalograph software	Neurology	882.1400	2
DRG	TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY	Cardiovascular	870.2910	2
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31658	Pulse oximeter probe, single-use	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. The is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841983102667	GS1
Unit of Use	00841983102660	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Adult