Duns Number:118380146
Device Description: 8" (20 cm) Appx 0.37 ml, Smallbore Pressure inf (400psig) Ext Set w/NanoClave® Y-Connector 8" (20 cm) Appx 0.37 ml, Smallbore Pressure inf (400psig) Ext Set w/NanoClave® Y-Connector, Purple Clamp, RL
Catalog Number
-
Brand Name
ICU Medical
Version/Model Number
A1116
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
K100576,K100576
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
04952e13-07d7-41c9-ac6b-5c1b9434fa8f
Public Version Date
April 07, 2021
Public Version Number
6
DI Record Publish Date
April 16, 2017
Package DI Number
10887709079066
Quantity per Package
50
Contains DI Package
00887709079069
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. | 4887 |