Duns Number:622637544
Device Description: Bi-furcated SUB-Q set with safety, 24-gauge x 6mm needle, 70cm tubing w/dressing
Catalog Number
SAF-Q-206-G24-70
Brand Name
SAF-Q
Version/Model Number
SAF-Q-206-G24-70
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
K140131,K140131
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
077709ca-0af7-488c-8e99-848c6b624498
Public Version Date
October 05, 2020
Public Version Number
5
DI Record Publish Date
December 12, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 26 |