Duns Number:790605856
Device Description: USB patient data cable for PageWriter TC 50 (860310) and TC 70 (860315) Cardiographs with USB patient data cable for PageWriter TC 50 (860310) and TC 70 (860315) Cardiographs with 5 pin instrument and 8 pin Patient Interface Module socket. Class B. Length: 6.6" (2m). 1 cable = 1 sales unit
Catalog Number
989803164281
Brand Name
NOUN
Version/Model Number
Class B USB Patient Data Cable
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
-
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
2f64c46c-c3fd-425d-927a-73c7ef4820c2
Public Version Date
August 04, 2022
Public Version Number
6
DI Record Publish Date
December 21, 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 |