Duns Number:007941230
Device Description: Chart Paper Ekg Roll Tso Single Channel No Grid 10 Rolls/pack 50mm X 25m MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
CP40477A
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
4d496d91-e614-468d-a915-48938b79b515
Public Version Date
October 06, 2020
Public Version Number
1
DI Record Publish Date
September 28, 2020
Package DI Number
30885632058879
Quantity per Package
10
Contains DI Package
20885632058872
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 |