Aeda - CU MTA1 110US/3060/D-QR/AEDA AERIA 10PRO - Aeda Healthcare Limited

Duns Number:680255366

Device Description: CU MTA1 110US/3060/D-QR/AEDA AERIA 10PRO

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More Product Details

Catalog Number

-

Brand Name

Aeda

Version/Model Number

1M01M060037 Rev.C / CU-A2-155

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Device Record Status

Public Device Record Key

8019d132-da31-4c34-8078-194807720668

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 27, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AEDA HEALTHCARE LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12