Duns Number:790605856
Device Description: Tri-anim, Nasal Alar SpO2 Sensor, 24/CS. Curaplex and Philips co-branded Nasal Alar single Tri-anim, Nasal Alar SpO2 Sensor, 24/CS. Curaplex and Philips co-branded Nasal Alar single patient use multi-compatible SpO2 sensor. 24 sensors per case
Catalog Number
989803205401
Brand Name
Nasal Alar SpO2 Sensor
Version/Model Number
Tri-anim, Nasal SpO2 Sensor, 24/CS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
Prescription Use (Rx)
-
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
95ab891b-c4a6-4751-a2ec-7a29b671b89f
Public Version Date
October 28, 2022
Public Version Number
6
DI Record Publish Date
April 03, 2020
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |