DeVilbiss 3655PL-JCMH

GUDID 00085304001508

Compressor / Nebulizer JCMH Home Health Products

DEVILBISS HEALTHCARE LLC

Medical device air compressor

• Primary Device ID: 00085304001508
• NIH Device Record Key: 3a180883-dae7-4011-a897-0196abb23655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeVilbiss
• Version Model Number: 3655PL-JCMH
• Catalog Number: 3655PL-JCMH
• Company DUNS: 962175894
• Company Name: DEVILBISS HEALTHCARE LLC
• 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: 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

Customer Support Contacts

• Phone: 1-800-338-1988
• Email: somdhccustomerservice@devilbisshc.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085304001508 [Primary]
GS1	10885430400150 [Package]; Package: case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020932

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: 2016-09-09

On-Brand Devices [DeVilbiss]

• 1088530400881: PULMO-AIDE CANADA
• 00088530400747: FlexSet Mask, Gel - Small
• 00088530400716: FlexSet Mask, Silicone - Medium
• 00088530400679: Serenity Mask, Silicone - Medium
• 00088530400297: FlexSet Comfort Touch Nasal CPAP Mask (M)
• 00088530400259: Serenity Mask, ComfortTouch, Gel - Medium
• 00088530400242: Serenity Mask, ComfortTouch, Silicone - Medium
• 00088530400099: VACU-AIDE COMPACT Spencer, power supply, 12 V Cord
• 00088530400082: Glass Powder Blower
• 00088530400044: SLEEP CUBE AUTO PLUS NORTHERN EUROPE
• 00085304022473: 10-liter oxygen concentrator (international Model)
• 00085304008798: IntelliPAP AutoBilevel w/HH & HT&SmartLink Module&Data Card
• 00085304003779: Heater, Humidifier
• 00085304002635: E CYL W/IFILL POST ADAPTER, W/870 POST VALVE
• 00085304002338: Homecare Suction, North America
• 00085304001508: Compressor / Nebulizer JCMH Home Health Products
• 00085304000280: FlexSet Comfort Touch Silicone mask size M
• 00885394001164: IntelliPAP Standard w/HH & SmartLink Module & Data Card
• 00885304022466: 10-liter oxygen concentrator
• 00885304022312: Vacu-Aide QSU w batterty, Latin America
• 00885304022305: Vacu-Aide QSU, Latin America
• 00885304022299: Vacu-Aide Homecare Suction Unit w/Battery, Latin America
• 00885304022282: Vacu-Aide Homecare Suction Unit, Latin America
• 01008530402265: Compressor/nebulizer
• 10885304022159: IntelliPAP AutoBilevel w/HH - Latin America
• 10885304022142: IntelliPAP Bilevel S w/HH - Latin America
• 10885304022135: IntelliPAP AutoAdjust with Heated Humidifier - Latin America
• 10885304022128: IntelliPAP Standard Plus w/HH - Latin America
• 10885304022111: IntelliPAP Standard with Heated Humidifier - Latin America
• 10885304022104: IntelliPAP auto bilevel - Latin America
• 10885304022098: IntelliPAP Bilevel S - Latin America
• 10885304022081: IntelliPAP Auto Adjust - Latin America
• 10885304022074: IntelliPAP Standard - Latin America
• 00885304020936: D CYL W/IFILL POST ADAPTER, W/870 POST VALVE CANADA
• 00885304020929: C CYL W/IFILL POST ADAPTER, W/870 POST VALVE CANADA
• 00885304020912: M6 CYL W/IFILL POST ADAPTER, W/870 POST VALVE CANADA
• 00885304020875: DeVilbiss Blue AutoPlus (Rest of World)
• 00885304009238: IntelliPAP 2 Standard Plus CPAP - EUROPE
• 00885304020851: DEVILBISS BLUE STANDARD PLUS CPAP REST OF WORLD
• 0085304009443: DeVilbiss Blue Auto Plus CPAP
• 00885304012252: Oxygen PulseDose Conserver - I
• 00885304011903: Oxygen PulseDose Conserver - G
• 00885304011125: ML6 CYL W/CF REG FOR CANADA
• 00885304011026: ML6 CYLINDER W/CF REG EUROPE
• 00885304010074: M6 CYL W/IFILL POST ADAPTER, W/870 POST VALVE
• 00885304009689: 5-liter oxygen concentrator - Quiet Unit
• 00885304009634: Disposable Suction Canister for Japan
• 00885304009535: IntelliPAP AutoBilevel w/HH & SmartLink II, Module & Data Ca
• 00885304009528: IntelliPAP Bilevel S w/HH & SmartLink II, Module & Data Card
• 00885304009511: IntelliPAP AutoAdjust w/HH & SmartLink II