Dual Swivel Elbow - Medicomp

Duns Number:154454730

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More Product Details

Catalog Number

MC-4450

Brand Name

Dual Swivel Elbow

Version/Model Number

MC-4450

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)

-

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

BZA

Product Code Name

Connector, Airway (Extension)

Device Record Status

Public Device Record Key

3d2d85a5-4234-4b32-93b2-476c76adaa88

Public Version Date

October 21, 2020

Public Version Number

6

DI Record Publish Date

September 15, 2017

Additional Identifiers

Package DI Number

10858409005334

Quantity per Package

50

Contains DI Package

00858409005337

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MEDICOMP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 53
2 A medical device with a moderate to high risk that requires special controls. 5