Halo

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…

Registry build 21.09.26

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.

183manufacturers in China registered for this device type
31catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (54), Jiangsu (41), Guangdong (23). 33 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NAD
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Hubei V-Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 46
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Jinhua Jingdi Medical Supplies Co., Ltd. Jinhua Zhejiang Contract manufacturer 29
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Changzhou Recoo Healthcare Co., Ltd. Changzhou Jiangsu Contract manufacturer 19
Derma Sciences Nantong Incorporation Development Jiangsu Contract manufacturer 19
Henso Medical (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Huizhou Foryou Medical Devices Co., Ltd. Huizhou Guangdong Contract manufacturer 18
Jianerkang Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 18
Anhui Kangfu Industrial Foreign Trade Co., Ltd. Tianchang Anhui Contract manufacturer 18

Showing 12 of 183. All 183 manufacturers in China registered for Dressing, Wound, Occlusive

Record

Regulatory record for Halo
Listed by Medical Devices (PVT) Ltd., Pakistan
FDA product code NAD
Device type Dressing, Wound, Occlusive
Device class Class 1
Regulation 21 CFR 878.4020
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-05-31
Record revised 2026-02-16 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature -30 to 140 °F; Handling environment temperature -30 to 140 °F
Packaging Case of 200, pack of 200, case of 100, pack of 100
Distribution end date 2024-12-31

Catalogue Numbers

Catalogue numbers for Halo
Catalogue number Size Status
US 1216-10006 In distribution
1216-10002 In distribution
UK 1216-10020 In distribution
US 1216-10020 In distribution
1216-10000 In distribution
EU 1216-10020 In distribution
US 1216-10002 In distribution
US 1216-10000 In distribution
US 1216-10004 In distribution
1216-10006 In distribution
1216-10004 In distribution
US 1216-10010 In distribution
US 1216-10030 In distribution
EU 1216-10008 In distribution
US 1216-10034 In distribution
US 1216-10032 In distribution
UK 1216-10008 In distribution
US 1216-10008 In distribution
US 1216-10012 In distribution
1216-10010 In distribution
EU 1216-10002 Withdrawn
EU 1216-10030 Withdrawn
EU 1216-10006 Withdrawn
EU 1216-10010 Withdrawn
1216-10020 Withdrawn
1216-10030 Withdrawn
EU 1216-10004 Withdrawn
1216-10012 Withdrawn
EU 1216-10012 Withdrawn
EU 1216-10000 Withdrawn
1216-10008 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medline Medline Industries, Inc. 93
MemGard Dalian Orientech Co., Ltd. 89
Leukomed® BSN Medical, Inc. 74
ProCure Twin Med, LLC 62
Cardinal Health Cardinal Health 200, LLC 60
Rhino Rescue Wuxi Emsrun Technology Co., Ltd. 60
Vitale CellEra, LLC 59
McKesson Mckesson Medical-Surgical Inc. 50
ActivHeal Advanced Medical Solutions Ltd 49
3M™ Tegaderm™ 3M Company 44
DeRoyal Deroyal Industries, Inc. 39
Healqu Healqu, LLC 38

Showing 12 of 526. All products under Dressing, Wound, Occlusive

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer