Duns Number:118380146
Device Description: 91" (231 cm) Appx 3.2 ml, Ext Set, Bifuse, Smallbore w/2 Anti-Siphon Valves, 2 Clamps, Spi 91" (231 cm) Appx 3.2 ml, Ext Set, Bifuse, Smallbore w/2 Anti-Siphon Valves, 2 Clamps, Spinning Spiros™ w/Red Cap
Catalog Number
CH3976
Brand Name
ICU Medical
Version/Model Number
CH3976
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
K082806,K082806
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
652cfeed-a3e5-4ef9-aff3-7419707539ea
Public Version Date
August 04, 2021
Public Version Number
1
DI Record Publish Date
July 27, 2021
Package DI Number
10887709123332
Quantity per Package
50
Contains DI Package
00887709123335
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4887 |