Duns Number:007941230
Device Description: Chart Paper Ekg Fetal W/chart Wraps & Labels Z-fold Red Grid 152mm x90mm Disposable/sngle Chart Paper Ekg Fetal W/chart Wraps & Labels Z-fold Red Grid 152mm x90mm Disposable/sngle Use Latex Free Non Sterile MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
CP4305CA
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DSF
Product Code Name
RECORDER, PAPER CHART
Public Device Record Key
36de198e-bf6e-4a2b-8a19-5fc172e3a061
Public Version Date
October 06, 2020
Public Version Number
1
DI Record Publish Date
September 28, 2020
Package DI Number
50885632115873
Quantity per Package
80
Contains DI Package
10885632115875
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 |