AccessGUDID - DEVICE: Radius-7 (00843997012997)

GUDID

Device Identifier (DI) Information

Brand Name: Radius-7
Version or Model: 9837
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MASIMO CORPORATION

Primary DI Number: 00843997012997
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 780421038 *Terms of Use

Device Description: with Wi-Fi

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":	No
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?
46201	Pulse Co-oximeter	A portable, battery-powered, electronic device designed to detect hypoxia (oxygen deficiency at the tissue level) via the transcutaneous multiwave measurement and display of carboxy-haemoglobin saturation (SpCO) and typically other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), and haemoglobin concentration (SpHb); pulse rate and haematocrit may also be calculated. A light-emitting diode (LED) and a receiving detector in a probe applied to a body site (e.g., a fingertip) are used to make multiwave measurements using spectrophotometry. The device is used in healthcare settings or the home, often to evaluate carbon monoxide poisoning.	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
Storage Environment Atmospheric Pressure: between 540 and 1060 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Atmospheric Pressure: between 540 and 1060 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c704317-c5da-4119-915b-667ee60c0435
Public Version Date: October 01, 2019
Public Version Number: 1
DI Record Publish Date: September 23, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(949)297-7498
Email: TechService-US@masimo.com

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