Duns Number:002348191
Device Description: AF 275 x 4ML/H 2ML-60LO FH STD C,4"IN
Catalog Number
MT4060LSK2-CP
Brand Name
LMA
Version/Model Number
IPN046527
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
-
Product Code
MEB
Product Code Name
PUMP, INFUSION, ELASTOMERIC
Public Device Record Key
868f1309-b5ac-4711-8489-220ee41ccacd
Public Version Date
January 18, 2021
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
15060112312509
Quantity per Package
5
Contains DI Package
05060112312502
Package Discontinue Date
-
Package Status
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 |