Wisp 1093925
GUDID 00606959040038
L Wisp Mask, Clear Frame, wHeadgear, INTL
Respironics, Inc.
CPAP/BPAP nasal mask, reusable| Primary Device ID | 00606959040038 |
| NIH Device Record Key | ceb5f39b-6aa3-423d-88ef-1667cff8e196 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wisp |
| Version Model Number | 00 |
| Catalog Number | 1093925 |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959040038 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121631
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 | 2016-09-19 |
On-Brand Devices [Wisp]
| 00606959021280 | WISP MASK, CLEAR FRAME, wHeadgear, INTL SE |
| 00606959021273 | WISP MASK, FABRIC FRAME, W HDGR, INTL |
| 00606959021266 | WISP MASK, CLEAR FRAME, W HDGR, INTL |
| 00606959012912 | WISP MASK, FABRIC FRAME, WO HDGR, DOM |
| 00606959012905 | WISP MASK, CLEAR FRAME, WO HDGR, DOM |
| 00606959006836 | Wisp Mask, Clear Frame, wHeadgear, DOM |
| 00606959006829 | WISP MASK, FABRIC FRAME, W HDGR, DOM |
| 00606959040175 | WISP MASK, FABRIC FRAME, wHeadgear, CHN |
| 00606959040168 | WISP MASK, CLEAR FRAME, wHeadgear, CHN |
| 00606959040151 | XL WISP MASK, FABRIC FRAME, wHeadgear, JPN |
| 00606959040144 | L WISP MASK, FABRIC FRAME, wHeadgear, JPN |
| 00606959040137 | MW WISP MASK, FABRIC FRAME, wHeadgear, JPN |
| 00606959040120 | S,M WISP MASK, FABRIC FRAME, wHeadgear, JPN |
| 00606959040113 | P WISP MASK, FABRIC FRAME, wHeadgear, JPN |
| 00606959040106 | WISP MASK, CLEAR FRAME, wHeadgear, CHN SE |
| 00606959040090 | WISP MASK, CLEAR FRAME, wHeadgear, JPN SE |
| 00606959040083 | XL Wisp Mask, Fabric Frame, wHeadgear, INTL |
| 00606959040076 | L Wisp Mask, Fabric Frame, wHeadgear, INTL |
| 00606959040069 | S,M Wisp Mask, Fabric Frame, wHeadgear, INTL |
| 00606959040052 | P Wisp Mask, Fabric Frame, wHeadgear, INTL |
| 00606959040045 | XL Wisp Mask, Clear Frame, wHeadgear, INTL |
| 00606959040038 | L Wisp Mask, Clear Frame, wHeadgear, INTL |
| 00606959040021 | S,M Wisp Mask, Clear Frame, wHeadgear, INTL |
| 00606959040014 | P Wisp Mask, Clear Frame, wHeadgear, INTL |
| 00606959040007 | Wisp Youth Mask, Fabric Frame, wHeadgear, CHN |
| 00606959039995 | Wisp Youth Mask, Fabric Frame, wHeadgear, INTL |
| 00606959039988 | Wisp Youth Mask, Fabric Frame, wo Headgear, DOM |
| 00606959039971 | Wisp Youth Mask, Fabric Frame, wHeadgear, DOM |
| 00606959039964 | XL Wisp Mask, Fabric Frame, wo Headgear, DOM |
| 00606959039957 | L Wisp Mask, Fabric Frame, wo Headgear, DOM |
| 00606959039933 | P Wisp Mask, Fabric Frame, wo Headgear, DOM |
| 00606959039926 | XL Wisp Mask, Clear Frame, wo Headgear, DOM |
| 00606959039919 | L Wisp Mask, Clear Frame, wo Headgear, DOM |
| 00606959039902 | SM Wisp Mask, Clear Frame, wo Headgear, DOM |
| 00606959039896 | P Wisp Mask, Clear Frame, wo Headgear, DOM |
| 00606959037380 | Wisp Mask, USA, Fabric Frame, wHeadgear, DOM |
| 00606959051874 | Wisp Mask, Clear Frame with Headgear, Small-Medium, USA |
| 00606959050518 | Wisp Nasal Lab Mask, Clear Frame, Large, USA |
| 00606959050501 | Wisp Nasal Lab Mask, Clear Frame, Small-Medium, USA |
| 00606959050495 | Wisp Nasal Lab Mask, Fabric Frame, Large, USA |
| 00606959050471 | Wisp Nasal Lab Mask, Combopack, USA |
| 00606959050464 | Wisp Nasal Lab Mask, Clear Frame, USA |
| 00606959050457 | Wisp Nasal Lab Mask, Fabric Frame, USA |
| 00606959051928 | Wisp Mask, Fabric Frame with Headgear, Large, USA |
| 00606959051911 | Wisp Mask, Fabric Frame with Headgear, Small Medium, USA |
| 00606959051904 | Wisp Mask, Fabric Frame with Headgear, Petite, USA |
| 00606959051898 | Wisp Mask, Clear Frame with Headgear, X-Large, USA |
| 00606959051881 | Wisp Mask, Clear Frame with Headgear, Large, USA |
| 00606959051867 | Wisp Mask, Clear Frame with Headgear, Petite, USA |
| 00606959039698 | WispDreamWisp Magnetic Clips, Replacement Part |
Trademark Results [Wisp]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WISP 97573661 not registered Live/Pending |
Pacific Group Resorts, Inc. 2022-08-31 |
 WISP 88899572 not registered Live/Pending |
Hunter Fan Company 2020-05-04 |
 WISP 88621496 not registered Live/Pending |
Women in Security and Privacy (WISP) 2019-09-18 |
 WISP 88037444 not registered Live/Pending |
Copious Imaging LLC 2018-07-13 |
 WISP 87863472 not registered Live/Pending |
ZAKE IP HOLDINGS, LLC 2018-04-04 |
 WISP 87606676 not registered Live/Pending |
The Wine Group LLC 2017-09-13 |
 WISP 87451947 5340752 Live/Registered |
M. Arthur Gensler Jr. & Associates, Inc. 2017-05-16 |
 WISP 87054208 not registered Dead/Abandoned |
iGlass Technology, Inc. 2016-05-31 |
 WISP 87033860 not registered Dead/Abandoned |
Evolv LLC 2016-05-11 |
 WISP 86647321 5060481 Live/Registered |
FINIUM Enterprises 2015-06-01 |
 WISP 86540591 not registered Dead/Abandoned |
WISP, LLC 2015-02-20 |
 WISP 86533454 4920936 Live/Registered |
M. Arthur Gensler Jr. & Associates, Inc. 2015-02-12 |
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