Duns Number:058614483
Device Description: Neonatal-Adult SpO2 Sensor;OxiMax TM Technology
Catalog Number
-
Brand Name
Nellcor OxySoft
Version/Model Number
OxySoftNJ
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
K212555,K212555
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
95efa953-23f6-4b72-a638-471fb4a0b359
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 21, 2022
Package DI Number
20884521818986
Quantity per Package
24
Contains DI Package
10884521818989
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |