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Halo

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 1216-10008

by Medical Devices Inc.

Identity

Trade Name
Halo Vent Single IFAK, 1 Halo Vent, 5.5"x7.5" with CE Mark EUDAMED
Halo FDA UDI
Generic Name
Wound hydrogel dressing, non-antimicrobial FDA UDI
Device Name
Halo EUDAMED
Halo Vent Single 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 Vent 5.5" x 7.5" with CE mark. FDA UDI
Halo Vent Single 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 Vent. FDA UDI
Model / Reference
1216-10008 EUDAMEDFDA UDI
EU 1216-10008 FDA UDI
Description
Halo Vent Single 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 Vent 5.5" x 7.5" with CE mark. FDA UDI
Halo Vent Single 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 Vent. FDA UDI

Identifiers

Catalog Number
EU 1216-10008 FDA UDI
1216-10008 FDA UDI
Primary DI / UDI-DI
00850010608426 EUDAMEDFDA UDI
00850010608105 FDA UDI
Basic UDI-DI
08500106081216-10000NW EUDAMED
FDA Product Code
NAD FDA UDI
EMDN Code
M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
GMDN Term
Wound hydrogel dressing, non-antimicrobial FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class I FDA UDI
Regulation Number
878.4020 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Category: Wound hydrogel dressing, non-antimicrobial

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

Similar devices

Also classified as Wound hydrogel dressing, non-antimicrobial.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Devices Inc.

Sources (3)

  • FDA UDI 9f540a5f-429d-45c1-89e4-e9b203dda7f5 36 fields · synced Jun 18, 2026
  • FDA UDI c136e4f9-f0a9-491a-be14-d5d45e775f5a 37 fields · synced May 30, 2026
  • EUDAMED c48af0c8-0e07-4135-8b84-60b56f2b1c8c 61 fields · synced Jun 18, 2026