Duns Number:042928915
Device Description: Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock,
Catalog Number
-
Brand Name
BMS-2135.17S
Version/Model Number
BMS-2135.17S
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
FOZ
Product Code Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Public Device Record Key
10961b61-8b8b-433e-9341-f75c475b4fa6
Public Version Date
November 02, 2020
Public Version Number
2
DI Record Publish Date
September 09, 2019
Package DI Number
10850005864605
Quantity per Package
50
Contains DI Package
00850005864608
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 45 |