Duns Number:023904428
Device Description: Catheter, IV safety, push button, sterile, Pink, Winged 20G x 1.16 in
Catalog Number
-
Brand Name
McKesson
Version/Model Number
192-PB20116W
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
K952861,K952861,K952861
Product Code
FOZ
Product Code Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Public Device Record Key
6a0b2749-89f9-4944-965c-7bd93c5569d7
Public Version Date
November 26, 2019
Public Version Number
1
DI Record Publish Date
November 18, 2019
Package DI Number
40612479250176
Quantity per Package
4
Contains DI Package
20612479250165
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |