FDA.reportPublic FDA data

Halo

Primary DI
00850010608464
Brand
Halo
Company
Medical Devices, Inc.
Model
EU 1216-10012
Catalog number
EU 1216-10012
Device description
"Halo Vent IFAK, 1 Halo Seal, 1 Halo Vent, 5.5"" x 7.5"" with 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. Each package contains quantity: 1 Halo Seal, 1 Halo Vent."
Published
2023-05-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010608471PackageGS1200Not in Commercial Distribution
00850010608464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010608471008500106084718500106084710850010608471
00850010608464008500106084648500106084640850010608464

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-30 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Temperature-30 Degrees Fahrenheit140 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
800.828.4681info@medicaldevicesinc.com

Regulatory Flags#

DUNS number
101571834
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850010608228HaloUK 1216-10008UK 1216-100082026-02-20
00850010608525HaloUK 1216-10020UK 1216-100202026-02-20
00850010608235HaloUK 1216-10008UK 1216-100082026-02-20
00850010608532HaloUK 1216-10020UK 1216-100202026-02-20
00850010608006Halo1216-100001216-100002021-03-02
00850010608020Halo1216-100021216-100022021-03-02
00850010608044Halo1216-100041216-100042021-03-02
00850010608068Halo1216-100101216-100102021-03-02
00850010608129Halo1216-100061216-100062021-03-02
00850010608549HaloUS 1216-10034US 1216-100342025-12-18
00850010608556HaloUS 1216-10034US 1216-100342025-12-18
00850010608327HaloUS 1216-10032US 1216-100322025-01-07
00085001060833HaloUS 1216-10032US 1216-100322025-01-07
00850010608082Halo1216-100201216-100202021-03-02
00850010608105Halo1216-100081216-100082021-03-02
00850010608143Halo1216-100121216-100122021-03-02
00850010608204Halo1216-100301216-100302023-03-08
00850010608341HaloEU 1216-10000EU 1216-100002023-05-31
00850010608365HaloEU 1216-10002EU 1216-100022023-05-31
00850010608389HaloEU 1216-10004EU 1216-100042023-05-31

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Primary DI, Brand, Company table
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00850087488372CeeportCEEPORT INC.NAD2026-05-29
00850087488396CeeportCEEPORT INC.NAD2026-05-29
00850087488402CeeportCEEPORT INC.NAD2026-05-29
00850087488419CeeportCEEPORT INC.NAD2026-05-29
10840330701560ProCureTwin Med, LLCNAD2026-04-28
10840330701577ProCureTwin Med, LLCNAD2026-04-28
10840330701584ProCureTwin Med, LLCNAD2026-04-28
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10840330701621ProCureTwin Med, LLCNAD2026-04-28
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10840330701669ProCureTwin Med, LLCNAD2026-04-28
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00324357404145Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
00324357410078Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
10193489093902MEDLINEMEDLINE INDUSTRIES, INC.NAD2026-01-29
10735471024695PolyMemFERRIS MFG. CORP.NAD2026-01-14
10197344169566MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-12-12
10192253038811KendallCardinal Health 200, LLCNAD2025-11-21