Duns Number:216344051
Device Description: A lightweight sensor that attaches to the patient’s chest, monitoring whether they are sit A lightweight sensor that attaches to the patient’s chest, monitoring whether they are sitting, standing or lying down –on their left side, right side or back.
Catalog Number
66803060
Brand Name
LEAF™
Version/Model Number
66803060
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
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
-
Product Code
KMI
Product Code Name
Monitor, Bed Patient
Public Device Record Key
4a3b0ccb-a534-40a3-8091-0fbc21c067f7
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
February 22, 2022
Package DI Number
05000223497446
Quantity per Package
10
Contains DI Package
05000223497439
Package Discontinue Date
-
Package Status
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 | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 126 |
| U | Unclassified | 1 |