Duns Number:790605856
Device Description: 5-Lead Set, disposable, for single patient use, with protective shield, to measure ECG on 5-Lead Set, disposable, for single patient use, with protective shield, to measure ECG on IntelliVue Telemetry. AAMI color coded grabbers. Round (rd) peelable ribbon style wires. Wire length: 2,8 ft (85 cm). Connects directly to Patient Worn Device 862231 TRx4851A, 862439 TRx4841A, 862108 M2601B Transmitter. 1 Sales Unit = 20 single wrapped lead sets
Catalog Number
989803173151
Brand Name
ECG Electrodes
Version/Model Number
5 lead set Disp., Telemetry, AAMI
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)
-
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
2c2ac9a5-3d4c-4091-b56d-9f8a2cd58f98
Public Version Date
September 27, 2022
Public Version Number
8
DI Record Publish Date
November 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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |