Duns Number:013649151
Device Description: Starter pack for the Quick Connect SpO2 Sensor (989803161991) that includes 5 each of Adul Starter pack for the Quick Connect SpO2 Sensor (989803161991) that includes 5 each of Adult, Pediatric, Infant and Neonatal disposable grips.
Catalog Number
989803167111
Brand Name
MR Patient Care SpO2 Grip Starter Kit (20 piece)
Version/Model Number
SpO2 Grip Starter Kit (20 piece)
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
c7bd8314-67ec-4431-bd41-d9f505e936bd
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 |