Duns Number:118380146
Device Description: Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac IV, Waste Bag System a Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac IV, Waste Bag System and 10 cc Control Syringe
Catalog Number
46300-11
Brand Name
ICU Medical
Version/Model Number
46300-11
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
K932141,K932141
Product Code
DQO
Product Code Name
Catheter, intravascular, diagnostic
Public Device Record Key
cb3de867-d49e-49d2-802f-15fd757d73e7
Public Version Date
September 06, 2021
Public Version Number
1
DI Record Publish Date
August 29, 2021
Package DI Number
10887709121833
Quantity per Package
10
Contains DI Package
00887709121836
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 |