Duns Number:012177531
Device Description: Administration set for infusion containing 2 alcohol swabs, 1 infusion set, 2 gauze pads, Administration set for infusion containing 2 alcohol swabs, 1 infusion set, 2 gauze pads, and 2 bandages.
Catalog Number
720006
Brand Name
Administration Set
Version/Model Number
720006
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
LRS
Product Code Name
I.V. Start Kit
Public Device Record Key
54bcba21-9d0c-4be2-b00a-44d828fd3e1c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 13, 2017
Package DI Number
30301697200065
Quantity per Package
48
Contains DI Package
00301697200064
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. | 2 |