EMPACT 6+ Patient Hard Case Kit with Wall Cabinet - EMPACT 6+ Patient Hard Case Kit with Wall - Pro1tek

Duns Number:827067880

Device Description: EMPACT 6+ Patient Hard Case Kit with Wall Cabinet - 6+ Patient Kit with Bat Flashlight co EMPACT 6+ Patient Hard Case Kit with Wall Cabinet - 6+ Patient Kit with Bat Flashlight contains both Medical and Tactical devices. Tactical helps with the run, hit fit in an active shooter situation. Kit features Hemostatic Dressing and other bleeding control devices and supplies to help in a trauma situation.

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More Product Details

Catalog Number

-

Brand Name

EMPACT 6+ Patient Hard Case Kit with Wall Cabinet

Version/Model Number

B28300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

OVR

Product Code Name

Kit, First Aid, Talking

Device Record Status

Public Device Record Key

a7948a74-de93-47f8-8b76-b55dfe1ab96d

Public Version Date

June 04, 2021

Public Version Number

1

DI Record Publish Date

May 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRO1TEK" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29