Silicone Face Mask 000315000

GUDID 05707480006625

Reusable face mask

Ambu A/S

Resuscitator face mask, reusable

• Primary Device ID: 05707480006625
• NIH Device Record Key: f80732ed-b0e1-4584-a3c5-4e4d9817a95c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Face Mask
• Version Model Number: 000315000
• Catalog Number: 000315000
• 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: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480006625 [Package]; Contains: 05707480030453; Package: [100 Units]; In Commercial Distribution
GS1	05707480030453 [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: 2024-07-16
• Device Publish Date: 2022-12-08

On-Brand Devices [Silicone Face Mask]

• 05707480006656: Reusable face mask
• 05707480006649: Reusable face mask
• 05707480006632: Reusable face mask
• 05707480006625: Reusable face mask
• 05707480006601: Reusable face mask