Halo 1216-10002
GUDID 00850010608037
Halo Vent Combo Flat Package. 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.
Medical Devices Inc
Wound hydrogel dressing, non-antimicrobial| Primary Device ID | 00850010608037 |
| NIH Device Record Key | a62578dd-b5a6-4871-beac-7e30cb6548c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Halo |
| Version Model Number | 1216-10002 |
| Catalog Number | 1216-10002 |
| Company DUNS | 101571834 |
| Company Name | Medical Devices Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850010608020 [Primary] |
| GS1 | 00850010608037 [Package] Contains: 00850010608020 Package: [200 Units] In Commercial Distribution |
FDA Product Code
| NAD | Dressing, Wound, Occlusive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-10 |
| Device Publish Date | 2021-03-02 |
On-Brand Devices [Halo]
| 00850010608150 | Halo Vent Combo IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing, |
| 00850010608136 | Halo Seal Single IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing |
| 00850010608112 | Halo Vent Single IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing |
| 00850010608099 | Halo Vent 2 Pack IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing |
| 00850010608075 | Halo Seal IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing, inten |
| 00850010608051 | Halo XL. This device is a non-resorbable and non-sterile, occlusive wound dressing, intended to |
| 00850010608037 | Halo Vent Combo Flat Package. This device is a non-resorbable and non-sterile, occlusive wound d |
| 00850010608013 | Halo Seal Flat Package. This device is a non-resorbable and non-sterile, occlusive wound dressin |
| 00850010608211 | Halo Vent Combo IFAK with Pad. This device is a non-resorbable and non-sterile, occlusive wound |
Trademark Results [Halo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HALO 98784300 not registered Live/Pending |
Skin Safeguard Inc. 2024-10-03 |
 HALO 98767255 not registered Live/Pending |
Protect Animals With Satellites, LLC 2024-09-24 |
 HALO 98765686 not registered Live/Pending |
Powered by Halo Inc. 2024-09-23 |
 HALO 98691381 not registered Live/Pending |
OASIS CONSUMER HEALTHCARE LLC. 2024-08-09 |
 HALO 98685312 not registered Live/Pending |
ECD Lacrosse, Inc. 2024-08-06 |
 HALO 98678393 not registered Live/Pending |
Metsera, Inc. 2024-08-01 |
 HALO 98636398 not registered Live/Pending |
Seats Incorporated 2024-07-08 |
 HALO 98624804 not registered Live/Pending |
Samtec Inc. 2024-06-28 |
 HALO 98550340 not registered Live/Pending |
SYDUCT DIAGNOSTICS INC. 2024-05-14 |
 HALO 98529116 not registered Live/Pending |
WH Products, LLC 2024-05-01 |
 HALO 98473348 not registered Live/Pending |
Ultradent Products, Inc. 2024-03-28 |
 HALO 98454522 not registered Live/Pending |
Halo, Inc. 2024-03-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.