Duns Number:825673239
Device Description: AMSafe® 84" (213cm) 10 Drop Gravity Set w/Pre-Slit Port, MicroClave® Clear, Rotating Luer, AMSafe® 84" (213cm) 10 Drop Gravity Set w/Pre-Slit Port, MicroClave® Clear, Rotating Luer, Drop-In Pressure Infusion (400 psig) Ext Set w/MicroClave® Clear, Slide Clamp, Rotating Luer, Approx Priming Volume: 11.0mL
Catalog Number
MRS10P-84
Brand Name
AMSafe® 84" (213cm) 10 Drop Gravity 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
K964435,K964435
Product Code
FMG
Product Code Name
Stopcock, I.V. Set
Public Device Record Key
26146cfd-e8cc-4cf6-ab4f-9e9274c598a9
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
40704411004630
Quantity per Package
50
Contains DI Package
10704411004639
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 |