Duns Number:879187821
Device Description: Reli Gem Safety Infusion Set 23G x 3/4", 12" tubing
Catalog Number
GSIS23G-12
Brand Name
RELI®
Version/Model Number
GSIS23G-12
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
K170276,K170276,K170276
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
109e2639-a1e1-4fad-89dc-5a4e89341602
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
October 26, 2018
Package DI Number
20386120008732
Quantity per Package
9
Contains DI Package
10386120008735
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 471 |