Primary Device ID | 10848530091153 |
NIH Device Record Key | 19106c3d-6c1f-4a0e-9e55-8cba78cf579b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CPAP Accessories |
Version Model Number | CAP2004 |
Company DUNS | 141668116 |
Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
Device Count | 250 |
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 | 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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848530091156 [Primary] |
GS1 | 10848530091153 [Unit of Use] |
BZD | Ventilator, Non-Continuous (Respirator) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-02 |
Device Publish Date | 2024-07-25 |
00848530099862 | CPAP accessories kit |
00848530092535 | Filter and Check Valve Kit for SoClean |
00848530099732 | Pediatric Nasal CPAP Mask Cushion Replacement – Adult XS |
00848530099282 | Pediatric Nasal CPAP Mask Kit with L/XL Cushions |
00848530099268 | Pediatric Nasal CPAP Mask Kit with S/M Cushions |
00848530040536 | Replacement Headgear Clips for Sunset Masks with Removable Cushions - 1pr/pkg. |
10848530091153 | Soft Headgear Strap Covers |