Duns Number:141588017
Device Description: PRIMARY GEMSTAR SPLIT SET Non-Vented, Extension Set with Yellow Striped Tubing, Integral P PRIMARY GEMSTAR SPLIT SET Non-Vented, Extension Set with Yellow Striped Tubing, Integral PAV, 110 Inch
Catalog Number
1326101
Brand Name
GemStar
Version/Model Number
1326101
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
FRN
Product Code Name
Pump, infusion
Public Device Record Key
fd59e778-d8f6-4f51-b3d0-50139bdef148
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2016
Package DI Number
20887787006685
Quantity per Package
24
Contains DI Package
10887787006688
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. | 7 |