Duns Number:790605856
Device Description: Universal Clear Tab/Snap Adapter to Cardiograph Lead. Enables the connection from 3mm - 4m Universal Clear Tab/Snap Adapter to Cardiograph Lead. Enables the connection from 3mm - 4mm post banana plug coming from the Cardiograph to tab & snap style electrodes. 1 bag = 10 adapters. Adapter can be sterilyzed by ethylene oxide - Not steam sterilizable. Adapters are for use with Philips PageWriter TC Series Cardiographs 860315 and 860310
Catalog Number
989803166031
Brand Name
Philips
Version/Model Number
Clear Tab/Snap Adapter 10/bag
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
7c8205aa-36e1-45a6-ba9d-afba2313ae57
Public Version Date
February 21, 2022
Public Version Number
6
DI Record Publish Date
December 21, 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 |