Duns Number:790605856
Device Description: Long complete lead set for PageWriter TC Series Cardiographs, AAMI color coded. Consisting Long complete lead set for PageWriter TC Series Cardiographs, AAMI color coded. Consisting of 2 long arm leads (54" (1,37m)), 2 long leg leads (56" (1,42m)), 2 long 1 into 3 Trident leads (42" (1,07m)), 2 lead separators, 2.54 DIA, 2 Trident Yoke labels (V1-V3, V4-V6), 4 colered clips, 14x colored rings, 6 brown base rings and instructions for use. This lead set comes fully assembled. 1complete lead set = 1 sales unit
Catalog Number
989803151651
Brand Name
NOUN
Version/Model Number
Long Complete Lead Set AAMI
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
-
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
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
0d0cdcbb-eb86-4e8b-8008-5d55d8698d5c
Public Version Date
August 04, 2022
Public Version Number
8
DI Record Publish Date
January 26, 2017
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 |