Primary Device ID | 00848530106461 |
NIH Device Record Key | b058faaa-7d45-4337-b556-92cf58818520 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Peform Health PrecisionFit Full Face CPAP Mask - Mediom |
Version Model Number | PH0301 |
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 | true |
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 | 00848530106461 [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 | 2025-07-30 |
Device Publish Date | 2025-07-22 |
00848530106454 - Perform Health PrecisionFit Full Face CPAP Mask - Small | 2025-07-30 CPAP mask with cushion and headgear |
00848530106461 - Peform Health PrecisionFit Full Face CPAP Mask - Mediom | 2025-07-30CPAP mask with cushion and headgear |
00848530106461 - Peform Health PrecisionFit Full Face CPAP Mask - Mediom | 2025-07-30 CPAP mask with cushion and headgear |
00848530106478 - Peform Health PrecisionFit Full Face CPAP Mask- Large | 2025-07-30 CPAP Mask with cushion and headgear - Large |
00848530106485 - Perform Health PrecisionFit Full Face Cushion - Small | 2025-07-30 CPAP Cushion - Small |
00848530106492 - Perform Health PrecisionFit Full Face Cushion - Medium | 2025-07-30 CPAP Cushion - Medium |
00848530106508 - Perform Health PrecisionFit Full Face Cushion - Large | 2025-07-30 CPAP Cusion - Large |
10848530106710 - CPAP Carry Bag for ResMed AirSense 11 | 2025-07-29 CPAP Carry Bag |
00848530106447 - Oxygen Kit | 2025-07-25 Oxygen Kit- This kit: RES1107(4) RES3025 (2) RES032 (1) RES035 (1) RES012 (2) RES003 (1) |