Duns Number:439770017
Device Description: F9011P is a rubber belts used to fix limb electrodes for ECG.The rubber belt is made of bi F9011P is a rubber belts used to fix limb electrodes for ECG.The rubber belt is made of biocompatible natural rubber, without additives and not irritating. Width 17 +/- 1 mm Length 26 +/-0.5 cm
Catalog Number
F9011P
Brand Name
NA
Version/Model Number
F9011P
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)
Yes
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
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
94b3e0be-d6b1-480a-80c3-73f809e7084c
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |