Duns Number:118492643
Device Description: 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc pre-filled 18 GA Catheter 1 ea20 GA Catheter 1 eaSaline Flush (5cc pre-filled syringe) 1 eaPovidone Prep Pad 1 eaAlcohol Prep Pad 2 eaIV Administration Set 1 eaNeedle Free Valve with Luer Lock 1 eaConstricting Band 1 eaIV Catheter Dressing 1eaTransparent Film Dressing 1 eaAdhesive Bandage 1 ea2"x2" Gauze Pad (2 pack) 1 ea
Catalog Number
80-100
Brand Name
INTRAVENOUS INFUSION STARTER SET
Version/Model Number
11
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
LRS
Product Code Name
I.V. Start Kit
Public Device Record Key
452f76ad-77cf-44e8-ae0c-8e6e8415b8df
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |