Primary Device ID | 00848530061272 |
NIH Device Record Key | fe54e55f-789d-49b4-bc2d-2fa57f4675d0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Rubber Suction Elbow Connectors |
Version Model Number | RES028 |
Catalog Number | RES028 |
Company DUNS | 141668116 |
Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
Device Count | 6 |
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 | 877-578-6738 |
customerservice@sunsethcs.com |
Device Size Text, specify | 0 |
Special Storage Condition, Specify | Between 0 and 0 *Fragile |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848530061272 [Primary] |
GS1 | 10848530061279 [Unit of Use] |
GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-08-31 |
Device Publish Date | 2018-07-31 |
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 | 2025-07-30 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) |