Duns Number:825673239
Device Description: AMSafe-3® I.V. Administration Set91" (231 cm) Adjusts to 10, 15, 60 Drop Non-Vented Gravit AMSafe-3® I.V. Administration Set91" (231 cm) Adjusts to 10, 15, 60 Drop Non-Vented Gravity Admin Set with 2 Pre-Slit Ports, 2 MicroClave® Clear, Back Check Valve, 1 Ext. Set, Slide Clamp, Rotating Male Luer Lock. Approx. Priming Volume: 25mL
Catalog Number
MR8305
Brand Name
AMSafe-3® I.V. Administration 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
K101958,K101958
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
bbfb7093-85c6-4bc4-a847-42e1da419f3a
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
40704411005286
Quantity per Package
50
Contains DI Package
10704411005285
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 |