Duns Number:439770017
Device Description: Rubber balls for FIAB suction chest electrodes, Ø 25mm dimensions. F9007P model is used as Rubber balls for FIAB suction chest electrodes, Ø 25mm dimensions. F9007P model is used as a replacement of old rubber balls. They are made of blue PVC. LATEX free. FIAB compatible ref models F9002 – F9008 – F9015
Catalog Number
F9007P
Brand Name
NA
Version/Model Number
F9007P
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
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
962c3463-7bf2-4a1a-bb43-0daa3c89c4a5
Public Version Date
September 02, 2020
Public Version Number
2
DI Record Publish Date
June 13, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |