Duns Number:480797856
Device Description: Single patient use sensor application ear clip, recommended for adult, pediatric and neona Single patient use sensor application ear clip, recommended for adult, pediatric and neonatal patients with mature/intact skin
Catalog Number
-
Brand Name
Ear Clip easy
Version/Model Number
ECe-MI
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 2020
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,K101690,K071672,K041548,K041548,K071672,K101690,K151329
Product Code
DPZ
Product Code Name
Oximeter, Ear
Public Device Record Key
358bc304-a8f6-400b-8776-da04fb470d66
Public Version Date
May 14, 2020
Public Version Number
2
DI Record Publish Date
March 31, 2020
Package DI Number
17640121880817
Quantity per Package
24
Contains DI Package
07640121880810
Package Discontinue Date
April 01, 2020
Package Status
Not 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 |