Duns Number:825673239
Device Description: AMSafe® I.V. Administration Set 106”For use with Spectrum, Flo-Gard 6201 and 6301 series p AMSafe® I.V. Administration Set 106”For use with Spectrum, Flo-Gard 6201 and 6301 series pumps106” (2.6m), 10 drops/mL, Slide and Roller Clamp, Backcheck Valve,0.22 Micron Filter, (2) Pre-Piecred Injection Sites,Rotating Male Luer Lock with Retractable Collar,Approx. Priming Volume: 22mL
Catalog Number
FP106FI2
Brand Name
AMSafe® I.V. Administration Set 106”
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
965a0f23-2a2c-4814-8aa8-166468ef7354
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
July 22, 2019
Package DI Number
40704411010938
Quantity per Package
50
Contains DI Package
10704411010937
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 |