Duns Number:002348191
Device Description: AF 550 X 4ML/H 2ML-60LO DL FH STD C,4"IN
Catalog Number
MT4030LSK2-CP
Brand Name
ARROW
Version/Model Number
IPN914401
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
c0c2f191-f2b6-4ffd-ab68-5ccdb88eb762
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
January 15, 2021
Package DI Number
24026704647617
Quantity per Package
5
Contains DI Package
14026704647610
Package Discontinue Date
February 18, 2022
Package Status
Not 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 | 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 |