Duns Number:622637544
Device Description: 2" SUB-Q Single Lumen Tissue Infusion Set with safety, 27G Needle, 6mm needle w/Needle Fre 2" SUB-Q Single Lumen Tissue Infusion Set with safety, 27G Needle, 6mm needle w/Needle Free Injection Site, Box of 10
Catalog Number
SAF-Q-106-SNF-Q10
Brand Name
SAF-Q
Version/Model Number
SAF-Q-106-SNF-Q10
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
K140131,K140131
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
ccd46f7d-43a1-417e-aa30-88beb54d4bd2
Public Version Date
December 15, 2020
Public Version Number
1
DI Record Publish Date
December 07, 2020
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 |