FDA.reportPublic FDA data

Oxygen Kit

Primary DI
00848530108908
Brand
Oxygen Kit
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
APER004O2KIT
Device description
Oxygen Kit(2) RES1104S, (2) RES1107S, (1) RES3025G, (1) RE3050G, (2) RES018NS, (1) RES003NS
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGLOxygen Administration Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGLOxygen Administration KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530108908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530108908008485301089088485301089080848530108908

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration kitA collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530108854Breathing CircuitVC1001-R2026-05-12
00848530108861Breathing CircuitVC1001P-R2026-05-12
00848530108878Breathing CircuitVEN004-R2026-05-12
00848530080136Comfort Shoulder Bag for D CylindersCSBDCSBD2018-07-31
00848530089214Carry Bag for Portable Suction MachineSU100DC-BAGSU100DC-BAG2018-05-25
00848530100452Nebulizer AccessoriesNEB300-BAG2024-07-30
00848530086503Personal Device HolderCSBML6M72024-06-28
00848530086992Personal Device HolderCSBML6-Hardshell2024-06-28
00848530080143Wheelchair/Scooter Carrier for E CylindersCSBECSBE2018-07-31
00848530080150Comfort Shoulder Bag for B/M6 CylindersCSBM6CSBM62018-07-31
00848530080167Backpack for B/M6, C/M9 or Smaller CylindersCSBM6BPCSBM6BP2018-07-31
00848530080174Comfort Shoulder Bag for C/M9 CylindersCSBM9CSBM92018-07-31
00848530081942Flex O2 BagCSBM6FlexCSBM6Flex2018-07-31
00848530087173Backpack for D CylindersCSBDBPCSBDBP2018-07-31
00848530087784Cylinder Roller Bag & Backpack — Single D/E TankCSBD1RollerCSBD1Roller2018-07-31
00848530087968Bag for Compressor NebulizerNEB100-BAGNEB100-BAG2018-05-29
00848530108939Ventilator FilterVF005-22026-04-30
00848530108946Ventilator FilterVF003-22026-04-30
00848530108809Ventilator accessoryVEN0072026-04-27
00848530108847CPAP FilterCF1012-2PLC2026-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530104443Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530104450Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530105402Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530108915Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530108922Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530108595Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-13
00848530108601Repair LabelSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-13
00848530108526Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108533Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108625Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108762Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108649Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108663Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108687Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108646Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108660Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108684Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108571Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-09
00848530108588Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-09
00848530108434Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-02-18
00848530108311Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-02-11
00848530108304Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-26
00848530108229REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108243REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108250REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
10848530108226REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108236REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
10848530108240REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
10848530108257REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108007Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2025-12-12