LMA - Reservoir:275 ML Basal Rate: 4 ML/ HR; - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Reservoir:275 ML Basal Rate: 4 ML/ HR; Bolus:N/ACatheter: Incisional

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More Product Details

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

Product Characteristics

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 Details

Product Code

MEB

Product Code Name

PUMP, INFUSION, ELASTOMERIC

Device Record Status

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

Additional Identifiers

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

"TELEFLEX INCORPORATED" Characteristics
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