Duns Number:799772079
Device Description: NeoConnect 3" (8 cm) Large Bore Sampling Straw with ENFit Connector, Purple
Catalog Number
PEXT-3STNC
Brand Name
NeoConnect Straw
Version/Model Number
PEXT-3STBNC
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
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
19202705-e7e2-4392-9d5c-dff52a3eb58a
Public Version Date
June 10, 2020
Public Version Number
1
DI Record Publish Date
June 02, 2020
Package DI Number
10817584013329
Quantity per Package
50
Contains DI Package
00817584013322
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 183 |