Duns Number:141588017
Device Description: ColorGard LATEX-FREE MIDLENGTH SECONDARY I.V. SET, Convertible Pin, 40 Inch with Orange St ColorGard LATEX-FREE MIDLENGTH SECONDARY I.V. SET, Convertible Pin, 40 Inch with Orange Striped Tubing
Catalog Number
4052148
Brand Name
Plum
Version/Model Number
4052148
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
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
94e2016f-1e86-4759-9d4d-ceeb40e99a7a
Public Version Date
July 23, 2020
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
20887787007705
Quantity per Package
48
Contains DI Package
10887787007708
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 |