Duns Number:080593067
Device Description: INTRAVENOUS FLUID ADMINISTRATION SET 150 CM, VENTED, FILTER, Y SITE, NEEDLE 21G X 1 1/2 "
Catalog Number
M101
Brand Name
MEDADV
Version/Model Number
M101
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K083687,K083687
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
85454884-9177-4831-8a35-f169bf6e54ae
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
April 12, 2018
Package DI Number
10819667020163
Quantity per Package
20
Contains DI Package
00819667020166
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 40 |