Duns Number:002348191
Device Description: AutoFuser 275mL pump, 2mL/hr flow rate, with Pajunk 10” saturation catheter, 4.5” introduc AutoFuser 275mL pump, 2mL/hr flow rate, with Pajunk 10” saturation catheter, 4.5” introducer
Catalog Number
MC0020LSK10-CP
Brand Name
ARROW
Version/Model Number
IPN048018
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
K090300,K090300
Product Code
MEB
Product Code Name
PUMP, INFUSION, ELASTOMERIC
Public Device Record Key
2f67b4d4-7ba2-43c1-a58a-249243eca5dd
Public Version Date
February 21, 2022
Public Version Number
4
DI Record Publish Date
March 04, 2019
Package DI Number
24026704612301
Quantity per Package
5
Contains DI Package
14026704612304
Package Discontinue Date
February 18, 2022
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |