Duns Number:140727624
Device Description: KeepSafe Customized Yellow Line Kit
Catalog Number
049960402A
Brand Name
KeepSafe Customized Yellow Line Kit
Version/Model Number
049960402A
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
Yes
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
DRS
Product Code Name
Transducer, Blood-Pressure, Extravascular
Public Device Record Key
defdf994-e54d-40b1-bfaa-9d5aae94dd48
Public Version Date
January 23, 2019
Public Version Number
2
DI Record Publish Date
March 09, 2018
Package DI Number
20886333223972
Quantity per Package
10
Contains DI Package
00886333223978
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 347 |
2 | A medical device with a moderate to high risk that requires special controls. | 1205 |