Duns Number:058614483
Device Description: Pediatric SpO2 Sensor,Two Piece
Catalog Number
PI
Brand Name
Nellcor
Version/Model Number
PI
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2016
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012891,K012891
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
9d01f31e-f6a3-4cec-a098-417bbf58a9b2
Public Version Date
October 12, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10884522042178
Quantity per Package
24
Contains DI Package
20884522042175
Package Discontinue Date
September 24, 2016
Package Status
Not 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 |