DabirAir Micropressure - MedSurg Overlay (33" Wide) - DABIR SURFACES, INC.

Duns Number:079374086

Device Description: MedSurg Overlay (33" Wide)

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More Product Details

Catalog Number

-

Brand Name

DabirAir Micropressure

Version/Model Number

DA-3S3584-05-0L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Device Record Status

Public Device Record Key

4b17da5c-bc48-4cd4-93f2-a1c1764b00e4

Public Version Date

May 22, 2019

Public Version Number

1

DI Record Publish Date

May 14, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DABIR SURFACES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 104