Duns Number:141588017
Device Description: CONTINUUM LIFESHIELD LATEX-FREE PRIMARY I.V. SET, Convertible Piercing Pin, 111 Inch with CONTINUUM LIFESHIELD LATEX-FREE PRIMARY I.V. SET, Convertible Piercing Pin, 111 Inch with Removable 3-Port Pressure Activated Valve Manifold, 4-Way High-Flow Stopcock, Backcheck Valve and 2 Prepierced Injection Sites Piggyback with OPTION-LOK
Catalog Number
1911148
Brand Name
Lifeshield
Version/Model Number
1911148
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
93e8f82d-7e64-4cc4-9468-cf970ad1216e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2016
Package DI Number
20887787007590
Quantity per Package
48
Contains DI Package
10887787007593
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. | 7 |