AccessGUDID - DEVICE: WristOx2 Model 3150 with Bluetooth Low Energy (00849686051025)

GUDID

Device Identifier (DI) Information

Brand Name: WristOx2 Model 3150 with Bluetooth Low Energy
Version or Model: 3150
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NONIN MEDICAL, INC.

Primary DI Number: 00849686051025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 174959692 *Terms of Use

Device Description: Model 3150 WristOx2, BLE Wrist-Worn Pulse Oximeter

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
36118	Pulse oximetry telemetric monitoring system	An assembly of devices designed to continuously measure and wirelessly transmit haemoglobin oxygen saturation (SpO2) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102350	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9c61e7bb-4b8e-467f-a08e-eac7578786e0
Public Version Date: April 13, 2021
Public Version Number: 1
DI Record Publish Date: April 05, 2021