Duns Number:118380146
Device Description: 167" (424 cm) 60 Drop Primary Set w/4 MicroClave™, Remv 4 Gang 1o2™ Manifold w/Check Valve 167" (424 cm) 60 Drop Primary Set w/4 MicroClave™, Remv 4 Gang 1o2™ Manifold w/Check Valve, Easydrop Flow Controller, Rotating Luer, 1 Ext, Drop-In 8" Pressure Infusion (400 psig) Ext Set w/Remv MicroClave™
Catalog Number
B33844
Brand Name
ICU Medical
Version/Model Number
B33844
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
K100576,K100576
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
a13f3f9c-fb83-4b40-87aa-13d5111b324e
Public Version Date
September 01, 2021
Public Version Number
1
DI Record Publish Date
August 24, 2021
Package DI Number
10887709083414
Quantity per Package
25
Contains DI Package
00887709083417
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 |