Duns Number:096931706
Device Description: Infusion Set (5.0 ml/hr)
Catalog Number
-
Brand Name
Beeline motIV
Version/Model Number
BL1D005
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"
Yes
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
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
73e40393-2d93-4153-83c3-bae04d60b28c
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 2021
Package DI Number
10857362007072
Quantity per Package
10
Contains DI Package
00857362007075
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
cardboard box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 22 |