Duns Number:177655466
Device Description: This kit is provided to store and house miscellaneous items: roller pump knob colored caps This kit is provided to store and house miscellaneous items: roller pump knob colored caps, wire markers and tags, spare fasteners, tools that may be needed, and replacement air filter.
Catalog Number
803730
Brand Name
Terumo® Advanced Perfusion System 1
Version/Model Number
803730
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"
-
For Single-Use
-
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
K151349
Product Code
DTQ
Product Code Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Public Device Record Key
6a32438f-efda-4fa4-b7b2-885b25552c9b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 174 |