Duns Number:083171244
Device Description: Large bore tubing assembly with integral one-way valve.
Catalog Number
NL8508560
Brand Name
Integra Large Bore Tubing Set
Version/Model Number
NL8508560
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
K932769,K972994,K932769,K972994
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
4d3a19fe-43cf-4577-a5b5-96f6c751c404
Public Version Date
December 15, 2020
Public Version Number
5
DI Record Publish Date
September 22, 2015
Package DI Number
30381780072427
Quantity per Package
5
Contains DI Package
10381780072423
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |