FDA.reportPublic FDA data

Oxygen Kit

Primary DI
00848530083960
Brand
Oxygen Kit
Company
Sunset Healthcare Solutions, Inc.
Model
APAR008PLATINUMKITB
Device description
Invacare Platinum Kit with Humidifier This kit contains: (2) OF9002, (1) BFH6S, (1) BF1438, (1) RES050, (1) HUM008
Published
2025-05-19
Public version status
Update
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
00848530083960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530083960008485300839608485300839600848530083960

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530109141Oxygen, Bacteria & HEPA FilterOF11003BR2026-06-30
00848530109165Oxygen, Bacteria & HEPA FilterOF11005BR2026-06-30
00848530109295Oxygen kitAATH006O2KIT2026-06-11
00848530109462Nasal CPAP MaskCM060-KITLNV2026-07-15
00848530109479Nasal CPAP MaskCM060L-NV2026-07-15
00848530109486Nasal CPAP MaskCM060XL-NV2026-07-15
00848530109523Oxygen KitAHOW001O2KIT2026-08-20
00848530109592Ventilator FilterVF010-12026-08-20
00848530109608Ventilator FilterVF010F-12026-08-20
00848530109639Nasal CPAP MaskCM060SNH2026-08-24
00848530109646Nasal CPAP MaskCM060MNH2026-08-24
00848530109653CPAP MaskCM061SNH2026-08-24
00848530109660CPAP MaskCM061MNH2026-08-24
00848530109691CPAP HeadgearHG060B2026-09-09
00848530109721OXYGEN CONNECTOR/ADAPTERRES019-1PL2026-09-09
00848530109738CPAP FilterCF1015NS2026-08-31
00848530109783Oxygen AccessoryPOCBAG-P22026-09-09
00848530109813AerosolTUB100-1FT15MM2026-09-09
00848530109820Ventilation AccessoryVEN008NS2026-09-09
00848530109837Ventilation AccessoryRES096MPNS2026-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00848530108250REPAIR PARTSunset Healthcare Solutions, Inc.OGL2026-01-19
10848530108226REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108236REPAIR PARTSSunset Healthcare Solutions, Inc.OGL2026-01-19