AccessGUDID - DEVICE: uSpO2 Pulse Oximetry Cable for GE ApexPro® CH, CARESCAPE™ Telemetry T4 & T14 (00843997011433)

GUDID

Device Identifier (DI) Information

Brand Name: uSpO2 Pulse Oximetry Cable for GE ApexPro® CH, CARESCAPE™ Telemetry T4 & T14
Version or Model: 3449
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3449
Company Name: MASIMO CORPORATION

Primary DI Number: 00843997011433
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 780421038 *Terms of Use

Device Description: uSpO2 Pulse Oximetry Cable for GE ApexPro® CH, CARESCAPE™ Telemetry T4 & T14

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?
36554	Patient monitoring system module, pulse oximetry	A small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between 10 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: dcf016ac-a749-4840-bb1a-ee12e6cab8d0
Public Version Date: June 06, 2023
Public Version Number: 3
DI Record Publish Date: August 24, 2016