Duns Number:013649151
Device Description: Fiber Optic SpO2 Sensor for use with Wireless SpO2 Module (989803163111) and Quick Connect Fiber Optic SpO2 Sensor for use with Wireless SpO2 Module (989803163111) and Quick Connect SpO2 accessories
Catalog Number
989803161991
Brand Name
Quick Connect SpO2 Probe, MRI
Version/Model Number
Quick Connect SpO2 Probe, MRI
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
020dcba9-77eb-43ea-bfed-82676b6ca859
Public Version Date
August 17, 2022
Public Version Number
7
DI Record Publish Date
November 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 650 |
| U | Unclassified | 4 |