DeVilbiss 535I-ML6-CF
GUDID 00885304011026
ML6 CYLINDER W/CF REG EUROPE
DEVILBISS HEALTHCARE LLC
Fixed-regulator oxygen cylinder| Primary Device ID | 00885304011026 |
| NIH Device Record Key | d6daca8e-01d4-431f-86c2-943dfbb69a18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DeVilbiss |
| Version Model Number | 535I-ML6-CF |
| Catalog Number | 535I-ML6-CF |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885304011026 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K053240
FDA Product Code
| CAW | Generator, Oxygen, Portable |
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 | 2016-09-12 |
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 |
Trademark Results [DeVilbiss]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DEVILBISS 98348137 not registered Live/Pending |
Shanghai Fuji E-commerce Co., Ltd 2024-01-09 |
 DEVILBISS 78978838 3314902 Live/Registered |
CARLISLE FLUID TECHNOLOGIES, INC. 2004-06-04 |
 DEVILBISS 78430350 not registered Dead/Abandoned |
Illinois Tool Works Inc. 2004-06-04 |
 DEVILBISS 74258630 1745662 Live/Registered |
DEVILBISS HEALTHCARE LLC 1992-03-24 |
 DEVILBISS 72157478 0771830 Live/Registered |
DeVilbiss Company, The 1962-11-19 |
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