Cough Assist
GUDID 00848530105433
Cough Assist Mouthpiece
SUNSET HEALTHCARE SOLUTIONS, INC.
Aerosol face mask, rebreathing, single-use| Primary Device ID | 00848530105433 |
| NIH Device Record Key | 7f141f2f-1d8b-4173-b2fb-c4712f5d8267 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cough Assist |
| Version Model Number | CAMP001-1 |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530105433 [Primary] |
FDA Product Code
| BYG | Mask, Oxygen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-11 |
| Device Publish Date | 2025-06-03 |
Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.
| 00848530106966 - Tracheostomy and Suction Accessory | 2025-08-22 18fr Chimney, Straight Packed Catheter |
| 10848530106970 - Tracheostomy and Suction Accessory | 2025-08-22 6fr Chimney, Straight Packed Catheter - Delee |
| 10848530106987 - Tracheostomy and Suction Accessory | 2025-08-22 8fr Chimney, Straight Packed Catheter - Delee |
| 10848530106994 - Tracheostomy and Suction Accessory | 2025-08-22 10fr Directional, Straight Packed Catheter |
| 10848530107007 - Tracheostomy and Suction Accessory | 2025-08-22 12fr Directional, Straight Packed Catheter |
| 10848530107014 - Tracheostomy and Suction Accessory | 2025-08-22 8fr Directional, Straight Packed Catheter - Delee |
| 10848530107021 - Suction Kit | 2025-08-22 10fr Chimney Catheter, Gloves, Cup - KIT |
| 10848530107038 - Suction Kit | 2025-08-22 12fr Chimney Catheter, Gloves, Cup - KIT |
Trademark Results [Cough Assist]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COUGH ASSIST 75940442 not registered Dead/Abandoned |
J.H. Emerson Co. 2000-02-22 |
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