ARROW - MAC(TM) Two-Lumen Central Venous Access Kit for - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters

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More Product Details

Catalog Number

ASK-11142-LC2

Brand Name

ARROW

Version/Model Number

IPN923736

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

K002507,K002507

Product Code Details

Product Code

FOZ

Product Code Name

Catheter, intravascular, therapeutic, short-term less than 30 days

Device Record Status

Public Device Record Key

d2090635-3296-4cd2-b1bb-4e7333d3e70f

Public Version Date

January 07, 2022

Public Version Number

2

DI Record Publish Date

December 29, 2021

Additional Identifiers

Package DI Number

20801902206804

Quantity per Package

5

Contains DI Package

10801902206807

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