Duns Number:884718776
Device Description: SUCTION CATHETER 6FR
Catalog Number
-
Brand Name
GLOBAL HEALTHCARE
Version/Model Number
83-C06
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"
Yes
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
JOL
Product Code Name
Catheter And Tip, Suction
Public Device Record Key
b812a133-c16f-4b5d-a573-c3a307ae47d0
Public Version Date
August 06, 2020
Public Version Number
4
DI Record Publish Date
September 12, 2016
Package DI Number
40872237003226
Quantity per Package
10
Contains DI Package
20872237003222
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 62 |