Ambu A/S

GUDID 04250105628098

Ambu Cuff Pressure Gauge

VBM Medizintechnik GmbH

Endotracheal tube cuff inflator

• Primary Device ID: 04250105628098
• NIH Device Record Key: f6d9ab99-a9c3-4eab-a457-afe0db5c4fd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambu A/S
• Version Model Number: 321900000
• Company DUNS: 324869601
• Company Name: VBM Medizintechnik GmbH
• 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: true
• Expiration Date: false
• 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: +49745495960
• Email: info@vbm-medical.de
• Phone: +49745495960
• Email: info@vbm-medical.de

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight and heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep away from sunlight and heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250105628098 [Direct Marking]
GS1	14250105628095 [Primary]
GS1	24250105628092 [Package]; Contains: 14250105628095; 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: 3
• Public Version Date: 2019-03-21
• Device Publish Date: 2018-03-26

On-Brand Devices [Ambu A/S]

• 14250105628088: Ambu Connecting Tube for Cuff Pressure Gauge
• 04250105628098: Ambu Cuff Pressure Gauge