Dual Swivel Elbow 15F/22M - 15M - Medicomp

Duns Number:154454730

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More Product Details

Catalog Number

MC-6450

Brand Name

Dual Swivel Elbow 15F/22M - 15M

Version/Model Number

MC-6450

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 20, 2021

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

0987e142-6a9d-459b-a0e2-c301cb8306c9

Public Version Date

September 21, 2021

Public Version Number

6

DI Record Publish Date

September 15, 2017

Additional Identifiers

Package DI Number

10858409005518

Quantity per Package

50

Contains DI Package

00858409005511

Package Discontinue Date

September 20, 2021

Package Status

Not 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