Duns Number:080456871
Device Description: Vital Signs™ Diagnostic Cardiology Care Cable
Catalog Number
22341808V
Brand Name
Vital Signs™
Version/Model Number
22341808V
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"
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
69b13250-9f81-480a-9bda-6c48d858db53
Public Version Date
April 06, 2021
Public Version Number
1
DI Record Publish Date
March 29, 2021
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 | 1068 |
2 | A medical device with a moderate to high risk that requires special controls. | 780 |
3 | A medical device with high risk that requires premarket approval | 65 |
U | Unclassified | 1 |