Primary Device ID | 10848530102019 |
NIH Device Record Key | 421cf5ae-2aab-445f-ab1e-1153b2f34af4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ResMed S9 and AirSense 10 Compatible Disposable Filters |
Version Model Number | AUSE001S910-52 |
Company DUNS | 141668116 |
Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
Device Count | 52 |
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 | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com | |
Phone | 877-578-6738 |
customerservice@sunsethcs.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848530102012 [Primary] |
GS1 | 10848530102019 [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 | 2024-03-20 |
Device Publish Date | 2024-03-12 |
10848530101807 - Celon Wet Bands 30.5 x 25mm | 2024-03-28 Celon Wet Bands 30.5x25mm |
10848530101814 - Celon Wet Bands 30.5 x 40mm | 2024-03-28 Celon Wet Bands 30.5x40mm |
10848530101821 - Celon Wet Bands 66 x 120mm | 2024-03-28 Celon Wets Bands 66x120mm |
10848530103504 - Löwenstein LUISA Ventilator and prisma Style Reusable CPAP Filter | 2024-03-28 Movair Luisa Ventilator Resuable Filter (OEM#WM29928) - 2/Pack |
10848530103511 - One Piece Tracheostomy Tie Adult 2.5cm x 43cm (17in) | 2024-03-28 Adult One Piece Trach Ties, 2.5x43cm (17in) - 20/box |
10848530103528 - One Piece Tracheostomy Tie Pediatric 2.5cm x 30cm (11.5in) | 2024-03-28 Pediatric One Piece Trach Ties, 2.5x30cm (11.5in) - 20/box |
10848530103535 - Two Piece Tracheostomy Tie Adult 2.5cm x 51cm (20in) | 2024-03-28 Adult Two Piece Trach Ties, 2.5x51cm (20in) - 20/box |
10848530103542 - Two Piece Tracheostomy Tie Pediatric 2cm x 25.5cm (10in) | 2024-03-28 Pediatric Two Piece Trach Ties, 2x25.5cm (10in) - 20/box |