FDA.report

Oxygen Regulator

Primary DI
00848530100469
Brand
Oxygen Regulator
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
RES046PL
Device description
***PRIVATE LABELED*** Mini CGA 870 Style O2 Regulator, 0-4lpm, Pediatric
Published
2024-06-03
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

Related Records

Contact Domains

Product Codes

CodeName
CANRegulator, Pressure, Gas Cylinder

Product Code Classifications

CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848530100469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530100469008485301004698485301004690848530100469

GMDN Terms

TermDefinition
Fixed-regulator oxygen refillable cylinderA container designed as a refillable cylinder with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes.

Sterilization Methods

Method

Contacts

PhoneEmail
877-578-6738customerservice@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
false
Serial number
true
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 DIBrandModelCatalogPublished
00848530108618CPAP FilterF-1382026-03-19
00848530108632CPAP TubingTUBE-962026-03-19
00848530108472Oxygen, Bacteria & HEPA FilterBF027-102026-03-17
00848530108489CPAP FilterA11FILTER12PK2026-03-17
10848530108646Repair PartsRP0972026-03-17
00848530108656Repair PartsRP0982026-03-17
10848530108660Repair PartsRP0992026-03-17
10848530108677Repair PartsRP1002026-03-17
10848530108684Repair PartsRP1042026-03-17
10848530108189Repair PartsRP1032026-03-09
10848530108196Repair PartsRP1052026-03-09
10848530108202Oxygen, Bacteria & HEPA FilterOF7003-102026-03-09
10848530108219Oxygen, Bacteria & HEPA FilterOF7005-102026-03-09
00848530108571Repair PartsRP101NS2026-03-09
00848530108588Repair PartsRP102NS2026-03-09
10848530108356Vented CPAP Masks VC10092026-03-03
10848530108363Vented CPAP Masks VC10102026-03-03
10848530108370Vented CPAP Masks VC10112026-03-03
10848530108387Vented CPAP Masks VC10122026-03-03
00848530108427Ventilator FilterVF005-12026-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850027043852Precision Medical Inc.Precision Medical, Inc.CAN2026-02-25
00819601025790Alcon Laboratories Inc.Airgas Therapeutics, LLCCAN2026-02-19
00848530108168RegulatorsSUNSET HEALTHCARE SOLUTIONS, INC.CAN2026-02-02
10848530108127RegulatorSUNSET HEALTHCARE SOLUTIONS, INC.CAN2026-01-26
10848530108158RegulatorSUNSET HEALTHCARE SOLUTIONS, INC.CAN2026-01-26
00199972000177CuraplexBOUND TREE MEDICAL, LLCCAN2026-01-23
00851440007483Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.CAN2025-12-13
00848530107765Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.CAN2025-11-24
16977645350528XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350535XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350542SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350559SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350566SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350573SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350580SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350597SINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350603XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350610XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350627XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350634XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350641XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
16977645350658XINYADanyang Xinya Valve Co., Ltd.CAN2025-11-17
10848530107410React Regulator ValveSUNSET HEALTHCARE SOLUTIONS, INC.CAN2025-09-17
08592346978812MediVital EGCE, s.r.o.CAN2025-08-08
16977645350184SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350276SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350207SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350214SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350382SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16
16977645350399SINYADanyang Xinya Valve Co., Ltd.CAN2025-06-16