Duns Number:007941230
Device Description: Patient Safety Alarm Nurse Call Cable Y-splitter Not Made With Natural Rubber Latex Reusab Patient Safety Alarm Nurse Call Cable Y-splitter Not Made With Natural Rubber Latex Reusable MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
PSNCY1
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
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
aa0d062a-9c6a-4cd6-b350-73c2c8011f9c
Public Version Date
October 01, 2020
Public Version Number
1
DI Record Publish Date
September 23, 2020
Package DI Number
20885632066976
Quantity per Package
200
Contains DI Package
10885632066979
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |