Duns Number:825673239
Device Description: AMSafe® I.V. Administration Set 109”For use with Spectrum, Flo-Gard 6201 and 6301 series p AMSafe® I.V. Administration Set 109”For use with Spectrum, Flo-Gard 6201 and 6301 series pumps109” (2.8m), 60 drops/mL, Slide and Roller Clamp, Backcheck Valve ,(3) Sure-Lok Needle-Free valves, Rotating Male Luer Lock with Retractable Collar,Approx. Priming Volume: 18 mL
Catalog Number
FP169BY3
Brand Name
AMSafe® I.V. Administration Set 109”
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
bcc5af62-75e7-4470-92bb-35b30763036b
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
July 22, 2019
Package DI Number
40704411010884
Quantity per Package
50
Contains DI Package
10704411010883
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
1
| 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 |