AccessGUDID - DEVICE: MasimoSET LNCS® TC-I SpO2 Reusable Ear Sensor (00843997000048)

GUDID

Device Identifier (DI) Information

Brand Name: MasimoSET LNCS® TC-I SpO2 Reusable Ear Sensor
Version or Model: 1895
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1895
Company Name: MASIMO CORPORATION

Primary DI Number: 00843997000048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 780421038 *Terms of Use

Device Description: MasimoSET LNCS TC-I SpO2 Reusable Ear Sensor

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37808	Pulse oximeter probe, reusable	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DPZ	Oximeter, ear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051212	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 56fa1618-f4bf-45b4-aeec-9f7235755560
Public Version Date: January 20, 2025
Public Version Number: 7
DI Record Publish Date: August 23, 2016