Duns Number:533172743
Device Description: The Sampling Kit Syringe is used for general purpose laboratory use. It is intended to be The Sampling Kit Syringe is used for general purpose laboratory use. It is intended to be used for specific medical use, such as collecting a sample from an IV bag and transferring it to laboratory tubes for further testing
Catalog Number
SK-35/2
Brand Name
Equashield
Version/Model Number
Sampling kit syringe
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"
-
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
KJG
Product Code Name
Tube, Tissue Culture
Public Device Record Key
00c55e3b-b8d5-44a0-b11f-cb11fed215f9
Public Version Date
February 01, 2022
Public Version Number
1
DI Record Publish Date
January 24, 2022
Package DI Number
17290013484632
Quantity per Package
24
Contains DI Package
07290013484635
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |