Duns Number:118380146
Device Description: 121" (307 cm) Appx 21.1 ml, 15 Drop Admin Set w/2 Clave™ Clear, Remv 2-Gang NanoClave™ Sto 121" (307 cm) Appx 21.1 ml, 15 Drop Admin Set w/2 Clave™ Clear, Remv 2-Gang NanoClave™ Stopcocks, Spin Luer, Drop-In Ext Set w/Remv Clave™ Clear
Catalog Number
AC241
Brand Name
ICU Medical
Version/Model Number
AC241
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
f8bee412-90b2-40bc-a6c0-417897549319
Public Version Date
August 30, 2021
Public Version Number
1
DI Record Publish Date
August 20, 2021
Package DI Number
10887709124520
Quantity per Package
50
Contains DI Package
00887709124523
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4887 |