Duns Number:825673239
Device Description: AMSafe® I.V. Administration Set with Pre-Attached Extension Set89" (226 CM) Long Non-Pyrog AMSafe® I.V. Administration Set with Pre-Attached Extension Set89" (226 CM) Long Non-Pyrogenic
Catalog Number
608304
Brand Name
AMSafe® I.V. Administration Set with Pre-Attached 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
8f477bd6-1c6b-4e4a-995b-2ebd9570424b
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 28, 2017
Package DI Number
40704411007044
Quantity per Package
50
Contains DI Package
10704411007043
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 |