ACU-EVAC - Consists of a charcoal/odor filter and an ULPA - ACUDERM, INC.

Duns Number:071426803

Device Description: Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particl Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..01 micron and 0.12 microns MPPS. Normal use filter life: 32 hours except for erbium smoke.

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More Product Details

Catalog Number

-

Brand Name

ACU-EVAC

Version/Model Number

M2-FILTER

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K930043

Product Code Details

Product Code

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Device Record Status

Public Device Record Key

2429cdac-182f-4c84-af2a-aa6ba1d707b9

Public Version Date

January 13, 2020

Public Version Number

1

DI Record Publish Date

January 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACUDERM, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 61