Duns Number:140727624
Device Description: Pressure Monitoring Lines Pressure Opaque PE Tubing 8Ft. Line w/Male & Female Luer Lock Co Pressure Monitoring Lines Pressure Opaque PE Tubing 8Ft. Line w/Male & Female Luer Lock Connectors
Catalog Number
040108001A
Brand Name
Pressure Monitoring Lines Pressure Opaque PE Tubing
Version/Model Number
040108001A
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
K781558,K781558
Product Code
DQO
Product Code Name
Catheter, Intravascular, Diagnostic
Public Device Record Key
8741527b-9551-4461-8f47-bca70413563b
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
20886333201000
Quantity per Package
25
Contains DI Package
00886333201006
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 | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1205 |