RESMED 16637
GUDID 00619498166374
FULL FACE MASK-CLIP/ RETAINER
RESMED LIMITED
Rebreathing oxygen face mask| Primary Device ID | 00619498166374 |
| NIH Device Record Key | f15b55d9-4909-41b2-a9ee-22a5e43de514 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RESMED |
| Version Model Number | 16637 |
| Catalog Number | 16637 |
| Company DUNS | 751149311 |
| Company Name | RESMED LIMITED |
| Device Count | 5 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00619498166374 [Primary] |
| GS1 | 10619498166371 [Unit of Use] |
| GS1 | 10619498166374 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K984428
FDA Product Code
| BZD | Ventilator, Non-Continuous (Respirator) |
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 | 2018-05-23 |
| Device Publish Date | 2016-09-12 |
On-Brand Devices [RESMED]
| 00619498607112 | Hospital NVFFM Headgear |
| 00619498368112 | TUBING WRAP SLIMLINE |
| 00619498339631 | TUBING WRAP |
| 00619498279661 | Astral PSU SlimLine |
| 00619498279630 | Homecare Stand (without interface) |
| 00619498279616 | Homecare Stand Astral plate |
| 00619498279357 | MEDICAL OXYGEN SENSOR |
| 00619498272013 | Connectivity Module |
| 00619498249916 | RESMED LEAK VALVE |
| 00619498249763 | RESMED LEAK PORT |
| 00619498249473 | RPS II BATTERY PACK |
| 00619498249237 | RESMED POWER STATION II |
| 00619498166374 | FULL FACE MASK-CLIP/ RETAINER |
| 00619498166244 | FULL FACE MASK VALVE ELBOW |
| 00619498166060 | FULLFACE MASK CUSHION LARGE |
| 00619498166053 | FULLFACE MASK CUSHION MEDIUM |
| 00619498166046 | FULLFACE MASK CUSHION SMALL |
| 00619498149995 | STANDARD TUBING, CLEAR-GRAY, 9' (2.74m) |
| 00619498149940 | STANDARD TUBING, CLEAR-GRAY, 6' (1.83m) |
| 00619498000746 | Strech Belt |
| 00619498249886 | RESMED LEAK VALVE |
Trademark Results [RESMED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESMED 86976322 4757707 Live/Registered |
RESMED PTY LTD 2013-10-03 |
 RESMED 86081966 5161373 Live/Registered |
RESMED PTY LTD 2013-10-03 |
 RESMED 85584745 4277247 Live/Registered |
RESMED PTY LTD 2012-03-30 |
 RESMED 79351744 not registered Live/Pending |
ResMed Pty Ltd 2022-08-12 |
 RESMED 79351363 not registered Live/Pending |
ResMed Pty Ltd 2022-08-12 |
 RESMED 79240984 not registered Live/Pending |
ResMed Limited 2018-07-12 |
 RESMED 77736032 3891826 Live/Registered |
RESMED PTY LTD 2009-05-13 |
 RESMED 77075051 not registered Dead/Abandoned |
Resvin Nutraceuticals Corp. 2007-01-03 |
 RESMED 75896295 2722982 Live/Registered |
RESMED PTY LTD 2000-01-13 |
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