Duns Number:118380146
Device Description: 8" (20 cm) Appx 0.45 ml, Ext Set, Bifuse, Smallbore w/2 Clave™, 2 Clamps, Spiros™ w/Red Ca 8" (20 cm) Appx 0.45 ml, Ext Set, Bifuse, Smallbore w/2 Clave™, 2 Clamps, Spiros™ w/Red Cap
Catalog Number
CH3979
Brand Name
ICU Medical
Version/Model Number
CH3979
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)
-
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
86062591-d88f-4066-9b67-4771a9ff5177
Public Version Date
July 21, 2021
Public Version Number
1
DI Record Publish Date
July 13, 2021
Package DI Number
10887709124216
Quantity per Package
50
Contains DI Package
00887709124219
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 |