Duns Number:968712278
Device Description: The convenience kit contains the following products:Propeller Sensor Model II (GTIN-14: 00 The convenience kit contains the following products:Propeller Sensor Model II (GTIN-14: 00865528000006)Propeller Sensor Model 2014-D (GTIN-14: 00865528000037)Qualcomm 2Net Hub (GTIN-14: 0100857803004014)
Catalog Number
-
Brand Name
Propeller
Version/Model Number
Convenience Kit - HUB/SMII/SM2014-D
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
69d9066b-da2d-487b-adac-4f56c16df4bd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 22, 2016
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. | 8 |