AccessGUDID - DEVICE: Adhesive Disposable SpO2 Sensors with Micro Foam Tape

GUDID

Device Identifier (DI) Information

Brand Name: Adhesive Disposable SpO2 Sensors with Micro Foam Tape - Infant
Version or Model: CST020-2403
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDIAID INC

Primary DI Number: B425CST02024032
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134990550 *Terms of Use

Device Description: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the Oximeter. The sensor contains three optical components, (LED) that serves as light sources and one photodiode that acts as light detector. The optical components are housed in adhesive film/rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated by a connector as specified by the different make/ manufacturer of the pulse Oximeter, with an optional adapter cable for compatible models.

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:	Yes
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?
17148	Pulse oximeter, line-powered	A mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041964	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
Storage Environment Temperature: between 5 and 45 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 45 Degrees Celsius
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e1e603b6-5780-444a-a5aa-e2cb01ed2681
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 25, 2016