Duns Number:316153865
Device Description: INFUSION POLE (SPRINTER CART/ SPRINTER CART XL)
Catalog Number
70103.3599
Brand Name
NA
Version/Model Number
INFUSION POLE
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
-
Product Code
KRI
Product Code Name
ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS
Public Device Record Key
f18599b1-c2f6-4447-bb4b-3eb5fae65295
Public Version Date
April 25, 2018
Public Version Number
3
DI Record Publish Date
February 19, 2016
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 286 |