Head Wedge™ 000264034

GUDID 05707480006359

Cervical Immobilization Device

Ambu A/S

Head/neck immobilizer, single-use

• Primary Device ID: 05707480006359
• NIH Device Record Key: 0eaabc78-f88e-49ca-b6cd-3a0216463261
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Head Wedge™
• Version Model Number: 000264034
• Catalog Number: 000264034
• Company DUNS: 305682023
• Company Name: Ambu A/S
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480006359 [Package]; Contains: 05707480024438; Package: [10 Units]; In Commercial Distribution
GS1	05707480024438 [Primary]
GS1	05707480024445 [Unit of Use]

FDA Product Code

• CCX: SUPPORT, PATIENT POSITION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-04
• Device Publish Date: 2022-12-08

On-Brand Devices [Head Wedge™]

• 05707480006373: Cervical Immobilization Device
• 05707480006359: Cervical Immobilization Device