Royal Flush - Royal Flush Plus High-Flow Catheter - COOK INCORPORATED

Duns Number:042823948

Device Description: Royal Flush Plus High-Flow Catheter

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More Product Details

Catalog Number

HN5.0-35-90-P-10S-0-01

Brand Name

Royal Flush

Version/Model Number

G58548

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"

-

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

K180054,K180054

Product Code Details

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Record Status

Public Device Record Key

a49b9c45-e681-4047-952d-a6e5c897a4a8

Public Version Date

November 20, 2020

Public Version Number

1

DI Record Publish Date

November 12, 2020

Additional Identifiers

Package DI Number

10827002585482

Quantity per Package

5

Contains DI Package

00827002585485

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Each

"COOK INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 669
2 A medical device with a moderate to high risk that requires special controls. 8328
3 A medical device with high risk that requires premarket approval 370
U Unclassified 242