FDA.reportPublic FDA data

MedSource Regulator

Primary DI
00840155400467
Brand
MedSource Regulator
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-28310
Catalog number
Not Applicable
Device description
O2 Regulator (Brass Core, 2 DISS) 0-25
Published
2021-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
CANRegulator, Pressure, Gas Cylinder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840155400467PackageGS120In Commercial Distribution
00840155400450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840155400467008401554004678401554004670840155400467
00840155400450008401554004508401554004500840155400450

GMDN Terms#

Term, Definition table
TermDefinition
Fixed medical gas cylinder regulatorA gas-regulating component of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixtures) cylinder to lower high, variable gas pressure to a lower, constant working pressure. It includes a cylinder shut-off switch (i.e., cylinder valve), regulator controls, manometer(s), a refill port, and a safety relief valve to avoid excessive pressure due to increased ambient temperatures. It is intended to be permanently fitted by a manufacturer to the stem of a valveless (i.e., open) empty medical gas cylinder prior to filling.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041674552
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816703025475MedSource Emesis BagMS-17360-RCSNot Applicable2021-05-10
00816703026526MedSource Airway DevicesMS-23908-RCSNot Applicable2021-05-18
00816703027172MedSource Traction SplintMS-TLS-3-RCSNot Applicable2021-08-16
00816703020838MedSource PRN, Male Luer PrositeMS-830112016-06-30
00816703021118MedSource NP Needle Free ConnectorMS-899792016-06-30
00840155421042Nasopharyngeal Airway1011-450002025-07-15
00840155401419MedSource CathetersMS-87414Not Applicable2023-01-09
00840155406179MedSource CathetersMS-87416Not Applicable2023-01-09
00840155413870MedSource CathetersMS-87420Not Applicable2023-01-09
00840155413900MedSource CathetersMS-87422Not Applicable2023-01-09
00840155413931MedSource CathetersMS-87424Not Applicable2023-01-09
00840155413962MedSource CathetersMS-874202Not Applicable2023-01-09
00840155413993MedSource Winged CathetersMS-84214WNot Applicable2023-01-30
00840155414020MedSource Winged CathetersMS-84216WNot Applicable2023-01-30
00840155414051MedSource Winged CathetersMS-84218WNot Applicable2023-01-30
00840155414082MedSource Winged CathetersMS-842202WNot Applicable2023-01-30
00840155414112MedSource Winged CathetersMS-84220WNot Applicable2023-01-30
00840155414143MedSource Winged CathetersMS-84222WNot Applicable2023-01-30
00816703023129Elite CPR Face ShieldELITE-21105Not Applicable2021-04-20
00816703023143Elite CPR Face ShieldELITE-21106Not Applicable2021-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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