Duns Number:825673239
Device Description: AMSafe® 5 in. (13cm) MicroBore Bifurcated Ext. Setw/2 MicroClave, 2 removable clamps, Rota AMSafe® 5 in. (13cm) MicroBore Bifurcated Ext. Setw/2 MicroClave, 2 removable clamps, Rotating Male luer Approx. Priming Volume 1.2 mL
Catalog Number
MB4BR05
Brand Name
AMSafe® 5 in. (13cm) MicroBore Bifurcated Ext. 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
a2bb8bdc-38b2-4b31-a817-a52c0979ba1e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 26, 2016
Package DI Number
40704411005675
Quantity per Package
50
Contains DI Package
10704411005674
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 |