ARROW - AC3 AUSTRALIAN POWER CORD (16FT/5M) - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: AC3 AUSTRALIAN POWER CORD (16FT/5M)

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More Product Details

Catalog Number

IAA-14695

Brand Name

ARROW

Version/Model Number

IPN915872

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

-

Product Code Details

Product Code

DSP

Product Code Name

System, balloon, intra-aortic and control

Device Record Status

Public Device Record Key

324c2dcc-ef03-4178-938b-a32142bedd8c

Public Version Date

September 24, 2021

Public Version Number

1

DI Record Publish Date

September 16, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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