Duns Number:480797856
Device Description: A combination of single-use products intended to attach the Sentec sensors to conventional A combination of single-use products intended to attach the Sentec sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with mature/intact skin
Catalog Number
-
Brand Name
Patient Application Kit for mature intact skin
Version/Model Number
PAK-MI
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151329,K151329,K101690,K071672,K041548,K041548,K071672,K101690
Product Code
DPZ
Product Code Name
Oximeter, Ear
Public Device Record Key
f2b14699-1605-4eee-b0d9-ddbfbf265599
Public Version Date
October 04, 2021
Public Version Number
1
DI Record Publish Date
September 26, 2021
Package DI Number
17640121880961
Quantity per Package
12
Contains DI Package
07640121880964
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |