Duns Number:189670230
Device Description: 60" Bifurcated Orange Stripe Extension Set with non-IV Enteral Stepped Adapter with female 60" Bifurcated Orange Stripe Extension Set with non-IV Enteral Stepped Adapter with female luer lock and 2" orange stripe tube with universal adapter
Catalog Number
-
Brand Name
NeoDevices, Inc.
Version/Model Number
ND60ENY-C
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
6bfa1354-07fd-49e1-ab6c-03e19bfeb83e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
10816340027716
Quantity per Package
50
Contains DI Package
10816340022025
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 134 |