CoughAssist 325-9237
GUDID 00606959021600
CoughAssist, Patient Circuit, Infant
Respironics, Inc.
Mechanical positive pressure airway secretion-clearing device| Primary Device ID | 00606959021600 |
| NIH Device Record Key | 634e7223-b19e-410f-b6bd-3140ab741467 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoughAssist |
| Version Model Number | 00 |
| Catalog Number | 325-9237 |
| 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 | true |
| 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 -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 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959021600 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121955
FDA Product Code
| NHJ | DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT |
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 | 2016-09-23 |
On-Brand Devices [CoughAssist]
| 00606959021617 | CoughAssist, Mouthpiece with breathing house and filter |
| 00606959021600 | CoughAssist, Patient Circuit, Infant |
| 00606959021594 | CoughAssist, Patient Circuit, Toddler |
| 00606959021419 | CoughAssist 70 Series, Mouthpiece |
| 00606959021396 | CoughAssist 70 Series, Water Trap |
| 00606959021372 | CoughAssist 70 Series Circuit, Mouthpiece, 9ft |
| 00606959021365 | CoughAssist 70 Series Circuit, Adult Large, 9ft |
| 00606959021358 | CoughAssist 70 Series Circuit, Adult Medium, 9ft |
| 00606959021341 | CoughAssist 70 Series Circuit, Adult Small, 9ft |
| 00606959021334 | CoughAssist 70 Series Circuit, Toddler 9ft |
| 00606959021327 | CoughAssist 70 Series Circuit, Infant, 9ft. |
| 00606959021259 | CoughAssist 70 Series Circuit, Mouthpiece, 6ft |
| 00606959021242 | CoughAssist 70 Series Circuit, Trach, 6ft |
| 00606959021235 | CoughAssist 70 Series Circuit, Adult Large, 6ft |
| 00606959021228 | CoughAssist 70 Series Circuit, Adult Medium, 6ft |
| 00606959021211 | CoughAssist 70 Series Circuit, Adult Small, 6 ft |
| 00606959021204 | CoughAssist 70 Series, Toddler Circuit, 6ft |
| 00606959021198 | CoughAssist 70 Series, Circuit, Infant, 6ft |
| 00606959020498 | CoughAssist, Infant Face Mask |
| 00606959015289 | CoughAssist, Adapter, 22mm x 15mm |
| 00606959006737 | CoughAssist, Disposable Filter |
| 00606959006720 | CoughAssist, Patient Circuit, Trach |
| 00606959006713 | CoughAssist, Adult Facemask, Large, with hose, filter, and adapter |
| 00606959006706 | CoughAssist Patient Circuit, Medium |
| 00606959006690 | CoughAssist, Patient Circuit, Small |
| 00606959005570 | CoughAssist, E70, Japan |
| 00606959005563 | CoughAssist, E70, China |
| 00606959005556 | CoughAssist, E70, Brazil |
| 00606959005549 | CoughAssist, T70 |
| 00606959005532 | CoughAssist, E70 International |
| 00606959043091 | CoughAssist Adapter 22mm x 22mm |
| 00606959041530 | CoughAssist, Mouthpiece |
| 00606959041523 | CoughAssist Circuit Breathing F-EM2CA |
| 00606959041394 | CoughAssist 70 Series, 6ft clear tube |
| 00606959037472 | CoughAssist, Toddler Face Mask |
| 00606959037465 | CoughAssist, Adult Face Mask, Small |
| 00606959037458 | CoughAssist, Adult FaceMask, Medium |
| 00606959037441 | CoughAssist, Adult Face Mask, Large |
| 00606959037427 | CoughAssist 70 Series Circuit, Trach, 9ft |
| 00606959047143 | SMOOTH BORE TUBE, 22MM X 36" |
| 00606959044128 | Sapio, EasyCough |
| 00606959058477 | 00 |
Trademark Results [CoughAssist]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COUGHASSIST 76614948 3078219 Live/Registered |
RIC INVESTMENTS, LLC. 2004-10-06 |
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