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Halo

FDA UDI

Class I (US FDA UDI)

by Medical Devices Inc.

Identity

Trade Name
Halo FDA UDI
Generic Name
Wound hydrogel dressing, non-antimicrobial FDA UDI
Device Name
Halo Vent Combo IFAK with Pad and CE mark. 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. FDA UDI
Model / Reference
EU 1216-10030 FDA UDI
Description
Halo Vent Combo IFAK with Pad and CE mark. 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. FDA UDI

Identifiers

Catalog Number
EU 1216-10030 FDA UDI
Primary DI / UDI-DI
00850010608501 FDA UDI
FDA Product Code
NAD FDA UDI
GMDN Term
Wound hydrogel dressing, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4020 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Halo by Medical Devices Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Devices Inc.

Sources (1)

  • FDA UDI 08ac635b-e0b6-4c51-8896-b7178eb4c027 37 fields · synced Jun 8, 2026