Duns Number:884718776
Device Description: IV SET, DEHP FREE, 60 DROPS/ML, 84" LENGTH, CONICAL SPIKE WITH AIR VENT, CHECK VALVE, TWO IV SET, DEHP FREE, 60 DROPS/ML, 84" LENGTH, CONICAL SPIKE WITH AIR VENT, CHECK VALVE, TWO INJECTION SITES, ROLLER CLAMP, ROTATING LUER LOCK CONNECTOR.
Catalog Number
-
Brand Name
GLOBAL HEALTHCARE
Version/Model Number
81-007A
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
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
30dcaebc-c6fb-4bec-99cd-54c49e16dad5
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
September 12, 2016
Package DI Number
40872237008719
Quantity per Package
50
Contains DI Package
00872237008711
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 62 |