ARROW - Access Tray - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Access Tray

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More Product Details

Catalog Number

ASK-04001-SUH-S

Brand Name

ARROW

Version/Model Number

IPN045645

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

CAZ

Product Code Name

Anesthesia conduction kit

Device Record Status

Public Device Record Key

1b00c986-ac81-4bfb-b527-aaa5609bbcc6

Public Version Date

February 07, 2019

Public Version Number

5

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

30801902067167

Quantity per Package

5

Contains DI Package

00801902067166

Package Discontinue Date

September 05, 2018

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