Duns Number:007941230
Device Description: Chart Paper Ekg Z-fold 3-channel Red Grid 300/pd 215mm X 140mm Disposable/sngle Use Not Na Chart Paper Ekg Z-fold 3-channel Red Grid 300/pd 215mm X 140mm Disposable/sngle Use Not Nat Rubber Ltx Non Sterile MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
CP7988
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)
-
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
1c603ed7-12b2-4d92-b3ea-5a23ef93703a
Public Version Date
October 23, 2020
Public Version Number
1
DI Record Publish Date
October 15, 2020
Package DI Number
20885632057738
Quantity per Package
20
Contains DI Package
10885632057731
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 |