Rospital Productos Medicos - SUCTION CATHETER T-TYPE 10 FR. EA. - ATLAS MEDICAL PRODUCTS LLC

Duns Number:013112308

Device Description: SUCTION CATHETER T-TYPE 10 FR. EA.

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More Product Details

Catalog Number

AMP020210

Brand Name

Rospital Productos Medicos

Version/Model Number

AMP020210

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

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Device Record Status

Public Device Record Key

31f53423-0f7b-47fa-9687-9ed5a77cb9e1

Public Version Date

June 22, 2020

Public Version Number

1

DI Record Publish Date

June 13, 2020

Additional Identifiers

Package DI Number

10812460027810

Quantity per Package

100

Contains DI Package

00812460027813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER

"ATLAS MEDICAL PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 7