Duns Number:079636164
Catalog Number
-
Brand Name
Set, I.V. Fluid Transfer
Version/Model Number
1 PHARM-6
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
K850757,K850757
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
f6aacc26-588c-4912-ad84-30d37a320f8e
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
May 23, 2016
Package DI Number
10816513020018
Quantity per Package
50
Contains DI Package
00816513020011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 148 |