LMA - LMA Fastrach Multipack - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: LMA Fastrach Multipack

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More Product Details

Catalog Number

13200

Brand Name

LMA

Version/Model Number

IPN047997

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

-

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

K051993,K051993,K051993

Product Code Details

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Device Record Status

Public Device Record Key

44a511d1-3068-470d-aeb2-2885c9e0cb79

Public Version Date

September 10, 2019

Public Version Number

2

DI Record Publish Date

September 15, 2018

Additional Identifiers

Package DI Number

25060112311820

Quantity per Package

8

Contains DI Package

05060112311826

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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