Duns Number:175899459
Device Description: ADHESIVE SENSOR LNCS PDTX-3 PEDIATRIC 10-50(KG) W/ 3FT CORD
Catalog Number
MAS2318
Brand Name
NA
Version/Model Number
MAS2318
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 17, 2019
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
K092368,K092368
Product Code
NLF
Product Code Name
OXIMETER, REPROCESSED
Public Device Record Key
e42afd41-8644-4c50-a5e0-15a1fe5c0189
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
September 22, 2016
Package DI Number
20888551042496
Quantity per Package
24
Contains DI Package
10888551042499
Package Discontinue Date
April 17, 2019
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2763 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1372 |
| U | Unclassified | 20 |