Primary Device ID | 00848530070670 |
NIH Device Record Key | be5588c6-ab3a-4cbc-846a-8c7a2cb3817e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Heated CPAP Tube for DreamStation Series and PR System One |
Version Model Number | TUB006SSRP |
Company DUNS | 141668116 |
Company Name | SUNSET HEALTHCARE SOLUTIONS, 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 | true |
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 |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848530070670 [Primary] |
BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-03-13 |
Device Publish Date | 2024-03-05 |
00848530031640 - CPAP Filter | 2024-07-17 PR System One Style Ultrafine Filters - Private Label - No Tab 1/Pack |
00848530031718 - CPAP Filter | 2024-07-17 PR System One Style Ultrafine Filters and Foam Filters |
00848530031725 - CPAP Filter | 2024-07-17 PR System One Style Ultrafine Filters and Foam Filters |
00848530031749 - CPAP Filter | 2024-07-17 PR System One Style Ultrafine Filters - No Tab Bulk |
00848530031756 - CPAP Filter | 2024-07-17 PR System One Style Ultrafine Filters 6/Pack |
00848530036089 - CPAP Filter | 2024-07-17 PR System One Style Ultrafine Filters and Foam Filters |
00848530040468 - CPAP Filter | 2024-07-17 Premium Chinstrap |
00848530080112 - Chin Strap | 2024-07-17 Premium Chinstrap |