Duns Number:799772079
Device Description: NeoConnect 3" (8 cm) Large Bore Sampling Straw with ENFit Connector, Orange
Catalog Number
EXT-3STNC
Brand Name
NeoConnect Straw
Version/Model Number
EXT-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"
-
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
58ef85f8-d982-41c5-9b86-030fa5476a85
Public Version Date
June 10, 2020
Public Version Number
1
DI Record Publish Date
June 02, 2020
Package DI Number
10817584013312
Quantity per Package
50
Contains DI Package
00817584013315
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 |