Duns Number:595138793
Device Description: Male/Female Fitting Pressure Tubing with length 72"
Catalog Number
682072
Brand Name
PT72(180CM)
Version/Model Number
682072
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
DRS
Product Code Name
Transducer, Blood-Pressure, Extravascular
Public Device Record Key
e2e658d6-de85-4b07-ba6f-3bdccd909843
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
50886333620727
Quantity per Package
125
Contains DI Package
00886333620722
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvek Pouch
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 392 |