Duns Number:825673239
Device Description: AMSafe-3 EXT6 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamberwith AMSafe-3 EXT6 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamberwith 6" (152mm) attached extension set.Non-Pyrogenic fluid pathway. GRAVITY FEED ONLY. Two Split Septum Injection Sites. One Rotating Male Luer Lock Adapter. Two Needleless Injection Sites
Catalog Number
D38302
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
d239a7ac-e0b4-48f0-a244-b5aa31326dc2
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
40704411004043
Quantity per Package
50
Contains DI Package
10704411004042
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 |