LMA - ARROW AutoFuser Disposable Pain Control Pump - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: ARROW AutoFuser Disposable Pain Control Pump

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More Product Details

Catalog Number

MC0050LYK2-CP

Brand Name

LMA

Version/Model Number

IPN047886

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

-

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

0fd1bbf8-3313-4bfa-afcd-e3e556cb7828

Public Version Date

February 21, 2022

Public Version Number

5

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

24026704610550

Quantity per Package

5

Contains DI Package

14026704610553

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