FDA.reportPublic FDA data

Oxygen Kit

Primary DI
00848530110024
Brand
Oxygen Kit
Company
Sunset Healthcare Solutions, Inc.
Model
ADAPTO2SFTKIT
Device description
Oxygen Kit (6 RES1107S, 2 RES3025G, 2 RES012, 2 RES001, 1 RES031)
Published
2026-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00848530110024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530110024008485301100248485301100240848530110024

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530110000Ventilator AccessoryVCMPV001-A2026-11-03
00848530110130Nasal CPAP MaskCM060-KITSLAB2026-11-03
00848530110147Oxygen KitCM060-KITLLAB2026-11-04
00848530110192CPAP MaskCM061SLAB2026-11-04
00848530110208CPAP MaskCM061MLAB2026-11-04
00848530110215CPAP MaskCM061LLAB2026-11-04
00848530110222CPAP MaskCM061XLLAB2026-11-04
00848530110284Oxygen KitAEAG002PKIT2026-11-03
00848530110291Oxygen KitAEAG002CKIT2026-11-03
00848530110307Breathing CircuitVEN004-CAP2026-11-03
00848530109875Ventilator accessoryVCMPV0012026-10-27
00848530110086Oxygen, Bacteria & HEPA FilterBF1412-32026-10-27
00848530093686Oxygen, Bacteria & HEPA FilterBF40002026-10-19
00848530109790Ventilator FilterVF015-12026-10-19
00848530109929Nebulizer and CompressorACTFISH2026-10-19
00848530109936Nebulizer and CompressorACTBEAR2026-10-19
00848530110031Ventilator FilterVF010-502026-10-19
00084853011017CPAP FilterCF1010F-502026-10-14
00848530109745CPAP FilterCF1015-42026-10-14
00848530109844CPAP FilterCF1015-6PL2026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530110284Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-11-03
00848530110291Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-11-03
00848530109905Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-09-30
00848530109523Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-08-20
00848530109295Oxygen kitSunset Healthcare Solutions, Inc.OGL2026-06-11
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
00848530108908Oxygen KitSunset Healthcare Solutions, Inc.OGL2026-04-20
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