DiamondTemp Generator Adapter - AcQMap to DiamondTemp Generator Adapter - ACUTUS MEDICAL, INC.

Duns Number:844418199

Device Description: AcQMap to DiamondTemp Generator Adapter

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More Product Details

Catalog Number

800727

Brand Name

DiamondTemp Generator Adapter

Version/Model Number

800727

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)

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

DQK

Product Code Name

Computer, Diagnostic, Programmable

Device Record Status

Public Device Record Key

dc5ddbe5-8c73-4722-bfdc-d445414b4c8b

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACUTUS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 62