Duns Number:002348191
Device Description: Reservoir:275 ML Basal Rate: 4 ML/ HR; Bolus:N/ACatheter: Incisional
Catalog Number
MC0040LSK2-CP
Brand Name
LMA
Version/Model Number
IPN046851
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
Yes
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
e53e3387-5692-4745-adb6-09a18e9110ac
Public Version Date
March 11, 2022
Public Version Number
6
DI Record Publish Date
September 23, 2016
Package DI Number
24026704609677
Quantity per Package
5
Contains DI Package
14026704609670
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 |