Duns Number:825673239
Device Description: AMSafe® Extension Set8" (20.3 cm) Standard Bore Ext. Set with Removable MicroClave® Clear, AMSafe® Extension Set8" (20.3 cm) Standard Bore Ext. Set with Removable MicroClave® Clear, Pinch Clamp, Rotating Male Luer Lock. Approx. Priming Volume: 1.2mL
Catalog Number
MR3108
Brand Name
AMSafe® 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
56b6ef28-cc74-4605-a2fc-ab71d0099e42
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
40704411005224
Quantity per Package
100
Contains DI Package
10704411005223
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 |