Duns Number:118380146
Device Description: 86" (218 cm) Appx 10.4 ml, 20 Drop Admin Set w/Integrated ChemoClave™ Drip Chamber, Spiros 86" (218 cm) Appx 10.4 ml, 20 Drop Admin Set w/Integrated ChemoClave™ Drip Chamber, Spiros™ w/Red Cap
Catalog Number
CH3642
Brand Name
ICU Medical
Version/Model Number
CH3642
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
K081361,K081361
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
8d308225-07be-4d1d-ac38-a9817e4f1a6a
Public Version Date
August 04, 2021
Public Version Number
1
DI Record Publish Date
July 27, 2021
Package DI Number
10887709085913
Quantity per Package
50
Contains DI Package
00887709085916
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 |