Duns Number:118380146
Device Description: 42" (107 cm) Appx 4.8 ml, 15 Drop Admin Set w/Spiros™ w/Red Cap, Bag Hanger, Drop-In Prim 42" (107 cm) Appx 4.8 ml, 15 Drop Admin Set w/Spiros™ w/Red Cap, Bag Hanger, Drop-In Priming Cap
Catalog Number
CH3517
Brand Name
ICU Medical
Version/Model Number
CH3517
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
K070532,K070532
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
552f4e65-ed84-4934-a178-63458100b6c9
Public Version Date
August 04, 2021
Public Version Number
1
DI Record Publish Date
July 27, 2021
Package DI Number
10840619083431
Quantity per Package
50
Contains DI Package
00840619083434
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 |