Ambu Cuff Pressure Gauge 321900000

GUDID 05707480133086

Ambu Cuff Pressure Gauge, for inflating and testing cuffs Tube length 100 cm, luer type connection

Ambu A/S

Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator Endotracheal tube cuff inflator

• Primary Device ID: 05707480133086
• NIH Device Record Key: 26ebd95e-7b78-4455-9e64-61b34f45866e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambu Cuff Pressure Gauge
• Version Model Number: 321900000
• Catalog Number: 321900000
• Company DUNS: 305682023
• Company Name: Ambu A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480133079 [Primary]
GS1	05707480133086 [Package]; Contains: 05707480133079; Package: [42 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912723

FDA Product Code

• BSK: Cuff, tracheal tube, inflatable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-09-20

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