Primary Device ID | 00848530104986 |
NIH Device Record Key | a04eefbb-de99-4305-8faf-6909b06a6204 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Filter - Vent |
Version Model Number | VF003-4 |
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 | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848530104986 [Primary] |
GS1 | 10848530104983 [Package] Package: Case [125 Units] In Commercial Distribution |
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 | 2025-04-23 |
Device Publish Date | 2025-04-15 |
00848530105815 | ResMed Astral Style Inlet Filter Housing |
00848530105273 | Breas Vivo 45 Reusable Air Inlet Filter – 5/PK Comparable to OEM# 007104 |
00848530105266 | Breas Vivo 45 Disposable Air Inlet Filter - BULK Comparable to OEM# 007103 |
00848530105259 | Breas Vivo 45 Reusable Air Inlet Filter Comparable to OEM# 007104 – BULK - 500/case |
00848530104986 | ResMed Astral Style Inlet Filter (Comparable to OEM# 27939) - 4/pack |