Duns Number:013649151
Device Description: Box of 20 Disposable SpO2 finger grips designed for use with the Quick Connect SPO2 Sensor Box of 20 Disposable SpO2 finger grips designed for use with the Quick Connect SPO2 Sensor (989803161991) - Sized for Neonatal patients
Catalog Number
989803166581
Brand Name
MR Patient Care Neonatal SpO2 Grips (20)
Version/Model Number
Neonatal SpO2 Grips (20)
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
Yes
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
996e95bc-26dc-48c2-93da-f3daf0b58b90
Public Version Date
August 22, 2022
Public Version Number
4
DI Record Publish Date
May 03, 2021
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 |