Duns Number:002111896
Device Description: Electrocardiographic recording paper
Catalog Number
32028970
Brand Name
GE Healthcare
Version/Model Number
2104771-001
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
c71a03b1-9d2b-406b-96b8-26add866ed79
Public Version Date
April 27, 2018
Public Version Number
1
DI Record Publish Date
March 27, 2018
Package DI Number
50009336008990
Quantity per Package
16
Contains DI Package
00009336008995
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 | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 269 |
| 3 | A medical device with high risk that requires premarket approval | 1 |