Halo US 1216-10002

GUDID 00862213000433

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 Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00862213000433
• NIH Device Record Key: 77c4ab3d-2cfb-4c08-a073-00f8e7904eec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halo
• Version Model Number: US 1216-10002
• Catalog Number: US 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

• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com
• Phone: 800.828.4681
• Email: info@medicaldevicesinc.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862213000426 [Primary]
GS1	00862213000433 [Package]; Contains: 00862213000426; Package: Case [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: 2023-06-08
• Device Publish Date: 2023-05-31

On-Brand Devices [Halo]

• 00862213000495: Halo Vent Single IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing
• 00862213000471: Halo Seal Single IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing
• 00862213000457: Halo XL. This device is a non-resorbable and non-sterile, occlusive wound dressing, intended to
• 00862213000433: Halo Vent Combo Flat Package. This device is a non-resorbable and non-sterile, occlusive wound d
• 00862213000419: Halo Seal Flat Package. This device is a non-resorbable and non-sterile, occlusive wound dressin
• 00850010608518: Halo Vent Combo IFAK with Pad and CE mark. This device is a non-resorbable and non-sterile, occl
• 00850010608495: Halo Vent 2 Pack IFAK, 2 Halo Vents 5.5" x 7.5" with CE mark. This device is a non-resorbable an
• 00850010608471: Halo Vent IFAK, 1 Halo Seal, 1 Halo Vent, 5.5" x 7.5" with CE mark. This device is a non-resorba
• 00850010608457: Halo Seal IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing, inten
• 00850010608433: Halo Vent Single IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing
• 00850010608419: Halo Seal Single IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing
• 00850010608396: Halo XL. This device is a non-resorbable and non-sterile, occlusive wound dressing, intended to
• 00850010608372: Halo Vent Combo Flat Package. This device is a non-resorbable and non-sterile, occlusive wound d
• 00850010608358: Halo Seal Flat Package. This device is a non-resorbable and non-sterile, occlusive wound dressin
• 00850010608310: Halo Vent Combo IFAK with Pad, 1 Halo Seal, 1 Halo Vent, 1 Cotton Pad, 5.5" x 7.5" This device i
• 00850010608297: Halo Vent 2 Pack IFAK, 2 Halo Vents 5.5" x 7.5". This device is a non-resorbable and non-sterile
• 00850010608273: Halo Vent IFAK, 1 Halo Seal, 1 Halo Vent 5.5" x 7.5". This device is a non-resorbable and non-st
• 00850010608259: Halo Seal IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing, inten