Duns Number:825673239
Device Description: For use with Spectrum, Flo-Gard 6201 and 6301 series pumps100” (2.6m), 10 drops/mL, Slide For use with Spectrum, Flo-Gard 6201 and 6301 series pumps100” (2.6m), 10 drops/mL, Slide and Roller Clamp, Backcheck Valve,(2) Pre-Pierced Injection Sites,Rotating Male Luer Lock with Retractable Collar,Approx. Priming Volume: 16mL
Catalog Number
FP100BI2
Brand Name
AMSafe® I.V. Administration Set 100”
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
47abfb91-6476-4b80-b522-8e6c99c9a2cb
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
July 22, 2019
Package DI Number
40704411010914
Quantity per Package
50
Contains DI Package
10704411010913
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 |