Duns Number:137468570
Device Description: MOBI’s Fingertip Pulse Oximeter offers a noninvasive method for monitoring oxygen salutati MOBI’s Fingertip Pulse Oximeter offers a noninvasive method for monitoring oxygen salutation. Though its reading of peripheral oxygen saturation (SPO2). It is portable, lightweight and multi-functional that can perform the measurement within 10 seconds.
Catalog Number
-
Brand Name
MOBI
Version/Model Number
70299
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2025
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173123,K173123,K173123
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
95a5f9e5-c2b3-4b3e-8e95-0b1615e431b4
Public Version Date
February 19, 2021
Public Version Number
1
DI Record Publish Date
February 11, 2021
Package DI Number
10891040702996
Quantity per Package
6
Contains DI Package
00891040702999
Package Discontinue Date
December 31, 2025
Package Status
In Commercial Distribution
Package Type
Cardboard
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |