Duns Number:044611812
Device Description: PowerGlide Midline Catheter 18G, 10cm with Basic Tray
Catalog Number
M118100
Brand Name
PowerGlide Midline Catheter
Version/Model Number
M118100
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
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
3fa4288b-023f-4489-8cb8-763f85e9ae74
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 17, 2016
Package DI Number
30801741038106
Quantity per Package
10
Contains DI Package
00801741038105
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |