Duns Number:012430880
Device Description: EKG Paper Multi Channel HSI
Catalog Number
1025508
Brand Name
Henry Schein
Version/Model Number
1025508
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
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
d6714212-85d6-4a87-a99e-efa94c9c0d38
Public Version Date
October 26, 2018
Public Version Number
1
DI Record Publish Date
September 25, 2018
Package DI Number
20304040061903
Quantity per Package
15
Contains DI Package
10304040061906
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |