Duns Number:825673239
Device Description: AMSafe® 19" (48cm) Ext Set w/Flow Controller, MicroClave® Clear, Clamp, Rotating Luer, App AMSafe® 19" (48cm) Ext Set w/Flow Controller, MicroClave® Clear, Clamp, Rotating Luer, Approx Priming Volume: 2.5mL
Catalog Number
MRSFC-19
Brand Name
AMSafe® 19" (48cm) 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
K964435,K964435
Product Code
FMG
Product Code Name
Stopcock, I.V. Set
Public Device Record Key
c4788ee0-1ffc-454a-b5b8-e42667e0afc1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
40704411004890
Quantity per Package
50
Contains DI Package
10704411004899
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 |