Primary Device ID | 00848530106294 |
NIH Device Record Key | 64929e83-3c65-4e1c-bfe5-041c9792c236 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Respiratory Kit |
Version Model Number | RESCON005LK |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848530106294 [Primary] |
OGL | Oxygen Administration Kit |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-11 |
Device Publish Date | 2025-06-03 |
00848530080808 | This kit contains: 1 CM005M Deluxe Full Face CPAP Mask - Medium, 1 TUB06 Durable CPAP Tubing - 6 |
00848530080792 | This kit contains: 1 CM005L Deluxe Full Face CPAP Mask - Large, 1 TUB06 Durable CPAP Tubing - 6f |
00848530106294 | Respiratory Kit - Large 1 kit contains: (4) RES1107, (2) RES012, (1) RES031, (1) RES001, (1) RES |