DreamWear 1125011
GUDID 00606959026858
L, DreamWear Pillows, Sm Frm wo HGR, GBL
Respironics, Inc.
CPAP/BPAP nasal mask, reusable| Primary Device ID | 00606959026858 |
| NIH Device Record Key | c04e9098-010e-4980-ba40-b6b6c7d4e4d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DreamWear |
| Version Model Number | 00 |
| Catalog Number | 1125011 |
| Company DUNS | 080728314 |
| Company Name | Respironics, Inc. |
| 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 | false |
| 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
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 Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 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 | 00606959026858 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140980
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 | 2018-08-20 |
| Device Publish Date | 2017-01-04 |
On-Brand Devices [DreamWear]
| 00606959023116 | 00 |
| 00606959022980 | 00 |
| 00606959022324 | 00 |
| 00606959052291 | DreamWear SC UTN Fitpack Japan |
| 00606959052062 | DreamWear UTN Nasal, Fitpack WHGR, USA |
| 00606959049765 | DreamWear Gel Pillows, Starter Pack, INTL |
| 00606959049642 | DreamWear Under the Nose Nasal, Medium Frame w Hgr, Korea |
| 00606959049383 | Medium Wide, DreamWear Full, Small and Medium Frame, Korea |
| 00606959049376 | Small Wide, DreamWear Full, Small and Medium Frame, Korea |
| 00606959049369 | 00 |
| 00606959049352 | Small, DreamWear Full, Small and Medium Frame, Korea |
| 00606959048898 | DreamWear Under the Nose Nasal, Large Frame WHGR, CHN |
| 00606959048881 | DreamWear Under the Nose Nasal, Medium Frame WHGR, CHN |
| 00606959048874 | DreamWear Under the Nose Nasal, Small Frame WHGR, CHN |
| 00606959040496 | S-M DreamWear Under the Nose Nasal, Lg Frame wHeadgear, JPN |
| 00606959040489 | S-M DreamWear Under the Nose Nasal, Med Frame wHeadgear, JPN |
| 00606959040472 | S-M DreamWear Under the Nose Nasal, Sm Frame wHeadgear, JPN |
| 00606959040342 | DreamWear Under the Nose Nasal Mask, Wide Cushion, Medium Frame wHeadgear, Japan |
| 00606959040335 | M DreamWear Under the Nose Nasal, Med Frame wHeadgear, JPN |
| 00606959040328 | DreamWear Under the Nose Nasal, Med Frame wHeadgear, JPN |
| 00606959040311 | W DreamWear Under the Nose Nasal, Lg Frame wHeadgear, JPN |
| 00606959040304 | M DreamWear Under the Nose Nasal, Lg Frame wHeadgear, JPN |
| 00606959040298 | W DreamWear Under the Nose Nasal, Sm Frame wHeadgear, JPN |
| 00606959040274 | M DreamWear Under the Nose, Sm Frame wHeadgear, JPN |
| 00606959037670 | S-M DreamWear Under the Nose Nasal, Lg Frame wHeadgear, JPN |
| 00606959037656 | S-M DreamWear Under the Nose Nasal, Sm Frame wHeadgear, JPN |
| 00606959037571 | DreamWear Under the Nose Nasal, Med Frame wHeadgear, INTL |
| 00606959037564 | DreamWear Under the Nose Nasal, Fitpack, INTL |
| 00606959031135 | MW DreamWear Under the Nose Nasal, Lg Frame WO Headgear, GBL |
| 00606959031128 | L DreamWear Under the Nose Nasal, Large Frame WO Headgear, GBL |
| 00606959031111 | M DreamWear Under the Nose Nasal, Lg Frame WO Headgear, GBL |
| 00606959031104 | S DreamWear Under the Nose Nasal, Lg Frame WO Headgear, GBL |
| 00606959031098 | MW DreamWear Under the Nose Nasal, Sm Frame WO HGR, GBL |
| 00606959031081 | L DreamWear Under the Nose Nasal, Sm Frame WO Headgear, GBL |
| 00606959031074 | M DreamWear Under the Nose Nasal, Sm Frame WO Headgear, GBL |
| 00606959031067 | S DreamWear Under the Nose Nasal, Sm Frame WO HGR, GBL |
| 00606959031050 | MW DreamWear Under the Nose Nasal, Med Frame WO Headgear, GBL |
| 00606959031043 | L DreamWear Under the Nose Nasal, Med Frame WO HGR, GBL |
| 00606959031036 | M DreamWear Under the Nose Nasal, Med Frame WO Headgear, GBL |
| 00606959030961 | S DreamWear Under the Nose, Med Frame WO Headgear, GBL |
| 00606959030947 | DreamWear Under the Nose Nasal, Med Frame WO Headgear, GBL |
| 00606959030916 | DreamWear Under the Nose Nasal, Med Frame wHeadgear, GBL |
| 00606959030909 | DreamWear Under the Nose Nasal, FitPack |
| 00606959030893 | MW DreamWear Under the Nose, Lg Frame wHeadgear, GBL |
| 00606959030886 | L DreamWear Under the Nose, Lg Frame wHeadgear, GBL |
| 00606959030879 | M DreamWear Under the Nose, Lg Frame wHeadgear, GBL |
| 00606959030862 | S DreamWear Under the Nose, Large Frame wHeadgear, GBL |
| 00606959030855 | MW DreamWear Under the Nose, Sm Frame wHeadgear, GBL |
| 00606959030848 | L DreamWear Under the Nose, Sm Frame wHeadgear, GBL |
| 00606959030824 | M DreamWear Under the Nose, Sm Frame wHeadgear, GBL |
Trademark Results [DreamWear]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DREAMWEAR 87825688 not registered Live/Pending |
Springs Global US, Inc. 2018-03-08 |
 DREAMWEAR 87825680 not registered Dead/Abandoned |
Springs Global US, Inc. 2018-03-08 |
 DREAMWEAR 79170324 4995363 Live/Registered |
Koninklijke Philips N.V. 2015-06-25 |
 DREAMWEAR 78629997 not registered Dead/Abandoned |
PRIVATE LABEL COSMETICS, INC. 2005-05-13 |
 DREAMWEAR 78264942 2844982 Live/Registered |
Dreamwear, Inc. 2003-06-20 |
 DREAMWEAR 75753148 2747588 Dead/Cancelled |
Franco Manufacturing Co., Inc. 1999-07-16 |
 DREAMWEAR 72334175 0887553 Dead/Expired |
MAIDENFORM, INC. 1969-08-01 |
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