Halo - Halo Vent Combo IFAK. This device is a - Medical Devices Inc

Duns Number:101571834

Device Description: Halo Vent Combo IFAK. This device is a non-resorbable and non-sterile, occlusive wound dre Halo Vent Combo IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing, intended to cover a wound and to provide a mechanical barrier. The vented seal allows air, gases, and fluids to escape from inside the chest through the device. Each package contains quantity: 1 Halo Seal, 1 Halo Vent.

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More Product Details

Catalog Number

1216-10012

Brand Name

Halo

Version/Model Number

1216-10012

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"

Yes

For Single-Use

Yes

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Device Record Status

Public Device Record Key

f7c7fb2a-7ba9-43cd-9bb8-2123107824a6

Public Version Date

March 10, 2021

Public Version Number

1

DI Record Publish Date

March 02, 2021

Additional Identifiers

Package DI Number

00850010608150

Quantity per Package

200

Contains DI Package

00850010608143

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDICAL DEVICES INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8