Duns Number:097462979
Device Description: Mini rigid cardiac sucker, soft tip w/ side ports, 1/4" connector, 9" length
Catalog Number
14991S
Brand Name
Terumo Cardiovascular Systems
Version/Model Number
14991S
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
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
-
Product Code
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
860e1958-3697-4bc4-8374-c08a8947207b
Public Version Date
September 21, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
10817278011457
Quantity per Package
20
Contains DI Package
00817278011450
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 91 |