HEMO-CATH® - CATHERINE MCAULEY HOSPITAL 11.5F X 15CM - Medical Components, Inc.

Duns Number:038000253

Device Description: CATHERINE MCAULEY HOSPITAL 11.5F X 15CM HEMO-CATH® SILICONE CUSTOM TRAY

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More Product Details

Catalog Number

-

Brand Name

HEMO-CATH®

Version/Model Number

TRAY #373

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 03, 2017

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

LFJ

Product Code Name

CATHETER, SUBCLAVIAN

Device Record Status

Public Device Record Key

b4b4db87-a255-48c0-bfa3-bf3fc7fe8df6

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

April 29, 2016

Additional Identifiers

Package DI Number

50884908054342

Quantity per Package

5

Contains DI Package

00884908054347

Package Discontinue Date

November 03, 2017

Package Status

Not in Commercial Distribution

Package Type

box

"MEDICAL COMPONENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 2560