Duns Number:314101143
Device Description: OR 5-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code system AAMI a OR 5-Lead ECG Trunk Cable, AAMI/IEC. Trunk can be used for either color code system AAMI and IEC. 1 trunk cable per bag. Cable length = 2,7 m (9ft). Use with indicated 3-lead products
Catalog Number
989803170181
Brand Name
ECG Trunk Cable
Version/Model Number
CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DPS
Product Code Name
ELECTROCARDIOGRAPH
Public Device Record Key
e21f9974-cbc2-43f8-bc6e-6947fd69544e
Public Version Date
March 04, 2022
Public Version Number
7
DI Record Publish Date
October 13, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 209 |