Duns Number:141588017
Device Description: LIFESHIELD, Latex-Free, 3-PORT ADAPTER with 2 Removable CLAVE Ports and Locking Spin Colla LIFESHIELD, Latex-Free, 3-PORT ADAPTER with 2 Removable CLAVE Ports and Locking Spin Collar
Catalog Number
1241901
Brand Name
Lifeshield
Version/Model Number
1241901
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
FRN
Product Code Name
Pump, infusion
Public Device Record Key
560f545d-cd0d-43ad-8985-f2d981d48919
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
20887787005343
Quantity per Package
120
Contains DI Package
10887787005346
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |