Disposable Face Masks 000252052

GUDID 05707480021703

Face mask

Ambu A/S

Anaesthesia face mask, single-use

• Primary Device ID: 05707480021703
• NIH Device Record Key: 4c804ef8-8626-49ac-a534-26ffd00025ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Face Masks
• Version Model Number: 000252052
• Catalog Number: 000252052
• 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: +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

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480005598 [Package]; Package: [8 Units]; In Commercial Distribution
GS1	05707480021703 [Package]; Contains: 05707480023264; Package: [20 Units]; In Commercial Distribution
GS1	05707480023264 [Primary]

FDA Product Code

• BYG: MASK, OXYGEN

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: 2024-04-16
• Device Publish Date: 2022-12-08

On-Brand Devices [Disposable Face Masks]

• 05707480021741: Ambu disposable face mask, size large adult, with hook ring
• 05707480021734: Ambu disposable face mask, size medium adult, with hook ring
• 05707480005635: Ambu disposable face mask, size small adult/child, with hook ring
• 05707480021710: Ambu disposable face mask, size toddler, with hook ring,
• 05707480021703: Face mask
• 05707480021697: Ambu disposable face mask, size neonate