Primary Device ID | 00848530091088 |
NIH Device Record Key | 743555cc-564f-4a97-8ff5-8735c245ea5a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CPAP Mask Cushion |
Version Model Number | ACM002CUCM005M |
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 |
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 | 00848530091088 [Primary] |
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 | 2024-06-28 |
Device Publish Date | 2024-06-20 |
00848530091095 | Deluxe Full Face Mask Replacement Cushion — Large |
00848530091088 | Deluxe Full Face Mask Replacement Cushion — Medium |
00848530091064 | Deluxe Nasal Mask Replacement Cushion — Large |
00848530091057 | Deluxe Full Face Mask Replacement Cushion — Medium |
00848530091040 | Deluxe Full Face Mask Replacement Cushion — Small |
00848530090654 | Clearsight Deluxe Nasal Mask Replacement Cushion — Large |
00848530090647 | Clearsight Deluxe Nasal Mask Replacement Cushion — Medium |
00848530090630 | Clearsight Deluxe Nasal Mask Replacement Cushion — Small |
00848530085223 | Deluxe Nasal Mask Replacement Cushion - Small |