Primary Device ID | 00848530093051 |
NIH Device Record Key | e224ff0b-7184-4e89-ad7f-c644152c727c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CPAP Filer |
Version Model Number | CF1010-500 |
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 | false |
RX Perscription | false |
OTC Over-The-Counter | false |
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 | |
Phone | 8775786738 |
customerservice@sunsethcs.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848530093051 [Primary] |
JRL | Unit, Filter, Membrane |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-25 |
Device Publish Date | 2024-07-17 |
00848530030469 - CPAP Filter | 2024-07-25 Respironics Aria, Virtuoso, Duet, Quartet Style Ultrafine Filters Bulk |
00848530030551 - CPAP Filter | 2024-07-25 Respironics BiPAP Pro, Plus, Duet LX, Synchrony Style Foam Filter 1/Pack |
00848530030605 - CPAP Filter | 2024-07-25 Respironics BiPAP Pro, Plus, Duet LX, Synchrony Style Ultrafine Filters Bulk |
00848530031169 - CPAP Filter | 2024-07-25 Respironics M-Series Style Foam Filter - 1/Pack |
00848530032845 - CPAP Filter | 2024-07-25 ResMed S9 and AirSense 10 Style Hypoallergenic Filters 1/Pack |
00848530081201 - CPAP Filter | 2024-07-25 ResMed S9 and AirSense 10 Style Hypoallergenic Filters - 12/Pack |
00848530081782 - Oxygen Kit | 2024-07-25 |
00848530082949 - CPAP Filter | 2024-07-25 Resmed S-9 CPAP Filter - 2/Pack - Private Labeled |