Duns Number:825673239
Device Description: AMSafe® Microbore Extension Set6" (15 cm) Long Non-Pyrogenic
Catalog Number
IVE0151
Brand Name
AMSafe® Microbore Extension Set
Version/Model Number
1
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
c54fd19e-bcec-4f24-b3f0-dcc2c5284d6c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 07, 2017
Package DI Number
40704411006634
Quantity per Package
50
Contains DI Package
10704411006633
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 | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |