Duns Number:058614483
Device Description: Pediatric-Infant Foam Sensor Wrap; For use with Product Codes OXI-P/I and D-YS.
Catalog Number
-
Brand Name
Nellcor
Version/Model Number
FOAM P/I
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"
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
-
Product Code
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
9f2ffded-7219-4a03-988c-9384d50da3df
Public Version Date
June 03, 2022
Public Version Number
3
DI Record Publish Date
September 26, 2018
Package DI Number
20884522042816
Quantity per Package
2
Contains DI Package
10884522042819
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |