Immobilization Kit, with 000281151

GUDID 05707480006540

Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult

Ambu A/S

Cervical spine collar, single-use

• Primary Device ID: 05707480006540
• NIH Device Record Key: 91436cf7-eb9b-45e4-a7c2-a00c9254cc72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immobilization Kit, with
• Version Model Number: 000281151
• Catalog Number: 000281151
• Company DUNS: 305682023
• Company Name: Ambu A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480006540 [Package]; Contains: 05707480024667; Package: [30 Units]; In Commercial Distribution
GS1	05707480024667 [Primary]

FDA Product Code

• IQK: Orthosis, cervical

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: 2024-07-22
• Device Publish Date: 2022-12-08

On-Brand Devices [Immobilization Kit, with]

• 05707480038626: Ambu® Military Perfit ACE™ and Ambu® Military Head Wedge™, Adult
• 05707480037308: Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
• 05707480006557: Ambu® Mini Perfit ACE™ and Ambu® Head Wedge™, Small Pediatric and Pediatric
• 05707480006540: Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult