ARROW - Access Tray - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Access Tray

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More Product Details

Catalog Number

ASK-04001-VM1

Brand Name

ARROW

Version/Model Number

IPN045649

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

CAZ

Product Code Name

Anesthesia conduction kit

Device Record Status

Public Device Record Key

35355480-8842-458c-83e9-6c5c7750d912

Public Version Date

July 23, 2021

Public Version Number

7

DI Record Publish Date

October 17, 2018

Additional Identifiers

Package DI Number

30801902114236

Quantity per Package

5

Contains DI Package

40801902114233

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