AccessGUDID - DEVICE: rainbow® DCI-dc3 SpCO® SpMet® SpO2 Adult Direct Connect Reusable Sensor (00843997001663)

GUDID

Device Identifier (DI) Information

Brand Name: rainbow® DCI-dc3 SpCO® SpMet® SpO2 Adult Direct Connect Reusable Sensor
Version or Model: 2201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2201
Company Name: MASIMO CORPORATION

Primary DI Number: 00843997001663
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 780421038 *Terms of Use

Device Description: rainbow DCI-dc3 SpCO SpMet SpO2 Adult Direct Connect Reusable 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?
47582	Pulse Co-oximeter probe, reusable	A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection. Signals from the probe, produced by a light-emitting diode (LED) and a receiving detector, are used to calculate results which are digitally displayed on the Co-oximeter's computerized unit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080238	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 15 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between 15 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: 5e3d322e-4d82-4a81-966c-89320d2fc378
Public Version Date: December 22, 2025
Public Version Number: 6
DI Record Publish Date: August 23, 2016