Duns Number:825673239
Device Description: AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamberwith 7" at AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamberwith 7" attached extension set.One Split Septum Injection Site, One Needle-Free Injection Site, One Rotating Male Luer Lock AdapterLength=82”, Priming Volume=22mlNon-Pyrogenic fluid pathway. GRAVITY USE ONLY
Catalog Number
-
Brand Name
AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber
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
K101958,K101958
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
679d40a3-3872-4bb6-8dc6-8bff751ac44c
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
March 30, 2018
Package DI Number
40704411007501
Quantity per Package
50
Contains DI Package
10704411007500
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 |