Primary Device ID | 00848530082048 |
NIH Device Record Key | f6e60632-b690-44b2-abef-7dc1a53f0867 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 3B Luna Style Ultrafine Filters |
Version Model Number | CF8005 |
Catalog Number | CF8005 |
Company DUNS | 141668116 |
Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
Device Count | 12 |
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 | 877-578-6738 |
customerservice@sunsethcs.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848530082048 [Primary] |
GS1 | 10848530082045 [Unit of Use] |
JRL | Unit, Filter, Membrane |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-07-05 |
Device Publish Date | 2018-06-04 |
00848530040291 - Oxygen Masks | 2024-08-23 Sunset Breathing Mask, No Hook s - Adult Small |
00848530040307 - Oxygen Masks | 2024-08-23 Sunset Breathing Mask, No Hooks - Adult Medium |
00848530040314 - Oxygen Masks | 2024-08-23 Sunset Breathing Mask, No Hooks - Adult Large |
00848530104214 - Oxygen Masks | 2024-08-23 Sunset Breathing Mask, No Hooks - Infant |
00848530104221 - Oxygen Masks | 2024-08-23 Sunset Breathing Mask, No Hooks - Toddler |
10848530091290 - Power and Accessories | 2024-08-16 Portable Suction Machine DC Mobile Power Adapter |
00848530091378 - Portable Suction | 2024-08-16 Portable Suction Machine AC |
10848530091870 - Power and Accessories | 2024-08-16 Replacement Battery for SU100DC Portable Suction Machine |