AuraOnce 321100000U

GUDID 05707480025459

Ambu AuraOnce U Size 1

Ambu A/S

Laryngeal mask airway, single-use

• Primary Device ID: 05707480025459
• NIH Device Record Key: ae1a6263-2321-4cf9-a71c-408f7a99f520
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AuraOnce
• Version Model Number: 321100000U
• Catalog Number: 321100000U
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05707480025459 [Package]; Contains: 05707480025534; Package: [10 Units]; In Commercial Distribution
GS1	05707480025534 [Primary]
GS1	05707480114498 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• CAE: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-30
• Device Publish Date: 2022-12-08

On-Brand Devices [AuraOnce]

• 05707480025565: Ambu AuraOnce U Size 2.5
• 05707480025466: Ambu AuraOnce U Size 1.5
• 05707480025527: Ambu AuraOnce U Size 6
• 05707480025435: Ambu AuraOnce U Size 5
• 05707480025503: Ambu AuraOnce U Size 4
• 05707480025497: Ambu AuraOnce U Size 3
• 05707480025473: Ambu AuraOnce U Size 2
• 05707480025459: Ambu AuraOnce U Size 1