Duns Number:078550672
Device Description: DOSELOGIX TC35BLACK3P, 35mL, 3 Port
Catalog Number
TC35-3 N BLACK
Brand Name
Doselogix
Version/Model Number
TC35BLACK
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KYX
Product Code Name
Dispenser, Liquid Medication
Public Device Record Key
83666e15-7235-4fd6-ad85-44a59805d658
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 2022
Package DI Number
10813360023001
Quantity per Package
25
Contains DI Package
00813360023004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 132 |