Med Alliance - Direct Suction Adaptor - Med Michigan Holdings, LLC

Duns Number:097462979

Device Description: Direct Suction Adaptor

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More Product Details

Catalog Number

CCFDSA01

Brand Name

Med Alliance

Version/Model Number

CCFDSA01

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

-

Product Code Details

Product Code

GCY

Product Code Name

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Device Record Status

Public Device Record Key

3290b154-f4f4-4a3b-aa34-438f5064dd8b

Public Version Date

September 21, 2022

Public Version Number

3

DI Record Publish Date

March 27, 2018

Additional Identifiers

Package DI Number

10817278012645

Quantity per Package

25

Contains DI Package

00817278012648

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MED MICHIGAN HOLDINGS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 91