Duns Number:004245668
Device Description: EarlySense Sensor Assembly
Catalog Number
-
Brand Name
Heart and Respiration Rate Monitoring System powered by EarlySense
Version/Model Number
P211560
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
K180079,K180079,K180079
Product Code
BZQ
Product Code Name
Monitor, breathing frequency
Public Device Record Key
f2426991-43c3-4efe-a1d8-8d2bb23b88a7
Public Version Date
October 01, 2021
Public Version Number
1
DI Record Publish Date
September 23, 2021
Package DI Number
00887761975705
Quantity per Package
1
Contains DI Package
00887761981720
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 79 |
2 | A medical device with a moderate to high risk that requires special controls. | 301 |