Duns Number:595138793
Device Description: 6" Male/ Female Fittings High Pressure Device
Catalog Number
682248
Brand Name
HPT06 HIGH PRESSURE TUBING 6 INCH
Version/Model Number
682248
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
-
Product Code Name
-
Public Device Record Key
84ac30cb-9e5a-4cf1-bf00-1f1359c0a87d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 30, 2016
Package DI Number
50886333622486
Quantity per Package
50
Contains DI Package
00886333622481
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvek Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 392 |