Duns Number:009251992
Device Description: CABLE ASSEMBLY-3 WIRE ECG, AHA, LIFEPAK 1000
Catalog Number
11111-000016
Brand Name
3-Wire ECG Cable (Lead II) (AHA)
Version/Model Number
11111
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 16, 2020
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
04c525dc-f578-47e5-820f-d229b83d56e8
Public Version Date
November 25, 2020
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 588 |