Duns Number:962187964
Device Description: Interactive Breath Hold - Monitor System, US Power Cord & Convertor
Catalog Number
-
Brand Name
Monitor System, US Power Cord & Convertor
Version/Model Number
M43T1071
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
ddd56a9d-2326-4aae-a9ac-cb2424ab1ee5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 09, 2017
Package DI Number
10851607003157
Quantity per Package
5
Contains DI Package
00851607003150
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 19 |