AMS

GUDID 10822383524501

AMS, Power Neb

Drive Devilbiss Healthcare

Nebulizing system, non-heated

• Primary Device ID: 10822383524501
• NIH Device Record Key: 0359e358-45bf-4a32-98db-2e56efa66e80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS
• Version Model Number: 18081-AMS
• Company DUNS: 867673159
• Company Name: Drive Devilbiss Healthcare
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822383524504 [Primary]
GS1	10822383524501 [Package]; Contains: 00822383524504; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003344

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

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: 2018-07-06
• Device Publish Date: 2016-09-16

Devices Manufactured by Drive Devilbiss Healthcare

• 00822383012155 - Silver Sport 16" ReclBack: 2026-02-11
• 00822383012162 - Silver Sport 16" Full Arm: 2026-02-11
• 00822383012179 - Silver Sport 18" Det Desk: 2026-02-11
• 00822383012186 - Silver Sport 18" Full Arm: 2026-02-11
• 00822383012193 - Silver Sport 20" Det Desk: 2026-02-11
• 00822383012209 - Silver Sport 20" Full Arm: 2026-02-11
• 00822383034683 - Silver Sport HD 22": 2026-02-11
• 00822383034690 - Silver Sport 24" HD: 2026-02-11