FDA.reportPublic FDA data

Oxygen Kit

Primary DI
00848530106447
Brand
Oxygen Kit
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
RESO2KITAXPL
Device description
Oxygen Kit- This kit: RES1107(4) RES3025 (2) RES032 (1) RES035 (1) RES012 (2) RES003 (1)
Published
2025-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530106447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530106447008485301064478485301064470848530106447

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.

Sterilization Methods#

Method table
Method

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
00848530060725Bubble Humidifiers - 6psiRES050RES0502018-07-31
00848530060732Bubble Humidifiers - 6psiRES050-50RES050-502018-07-31
00848530062064Bubble Humidifiers - 6psiRES050-1RES050-12018-07-31
00848530108557CPAP FilterCF1013-22026-08-26
00848530090890Zoey CPAP CleanerZCD100ZCD1002020-02-28
00848530106430Heat Moisture ExchangerRES027SG2026-08-15
00848530109677CPAP Mask KitCM061-KITS2026-08-15
00848530109684CPAP Mask KitCM061-KITL2026-08-15
00848530109455Oxygen AccessoryRES031M-12026-07-23
00848530109509Ventilator FilterVIVOFILTERKIT2026-07-23
00848530109516CPAP FilterCF40042026-07-23
00848530109127Oxygen, Bacteria & HEPA FilterOF1001BR2026-06-23
00848530109134Oxygen, Bacteria & HEPA FilterOF1005BR2026-06-23
00848530109172Oxygen, Bacteria & HEPA FilterOF11006BR2026-06-23
00848530109189Oxygen, Bacteria & HEPA FilterOF3002BR2026-06-23
00848530109196Oxygen, Bacteria & HEPA FilterOF5001BR2026-06-23
00848530109202Oxygen, Bacteria & HEPA FilterOF6001BR2026-06-23
00848530109219Oxygen, Bacteria & HEPA FilterOF8002BR2026-06-23
00848530109226Oxygen, Bacteria & HEPA FilterOF9001BR2026-06-23
00848530109233Oxygen, Bacteria & HEPA FilterOF9002BR2026-06-23