FDA.reportPublic FDA data

The Harris Products Group

Primary DI
00850005066392
Brand
The Harris Products Group
Company
J. W. HARRIS CO., INC.
Model
REG,301-OX0.5L-540
Catalog number
3500681
Published
2019-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850005066392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005066392008500050663928500050663920850005066392

GMDN Terms#

Term, Definition table
TermDefinition
Medical air cylinder regulatorA reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical air cylinder to lower high, variable gas pressure (e.g., 50 - 250 bar) to a lower, constant working pressure (typically 3 - 5 bar). It can be a single- or dual-stage regulator, usually of a piston or diaphragm design. It includes a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may include associated devices, usually a manometer(s), to display the available gas reserve of the air cylinder and the working pressure.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004233490
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005066552The Harris Products GroupREG,301-50P BARE OXY35007512022-01-27
00850005066569The Harris Products GroupREG,301-50P BARE N2O35007522022-01-27
00850005066545The Harris Products Group FLOW/REG,601-OX15L-54035004012021-07-15
00850005066026The Harris Products GroupREG,301-N2015MC-326HT35005992020-05-19
00850005066064The Harris Products GroupREG,301-OX8MC-54035006062020-05-19
00850005066071The Harris Products GroupREG,301-OX8MC-87035006072020-05-19
00850005066088The Harris Products GroupREG,301-OX5M-87035006122020-05-19
00850005066125The Harris Products GroupREG,301-50PL-910 N2035006182020-05-19
00850005066217The Harris Products GroupREG,301-50PS BARE35006362020-05-19
00850005066224The Harris Products GroupREG,25-2C T50P-540 12 PK35006392020-05-19
00850005066231The Harris Products GroupREG,25-2C T50P-326 12 PK35006402020-05-19
00850005066385The Harris Products GroupREG,301-0X0.5M-87035006802020-05-19
00850005066408The Harris Products GroupREG,301-50PS BARE 6 PK35006872020-05-19
00850005066415The Harris Products GroupREG,301-OX5L-00035006892020-05-19
00850005066422The Harris Products GroupREG,301-OX5L-00035006912020-05-19
00850005066453The Harris Products GroupREG,301-CD100-94035007402020-05-19
00850005066514The Harris Products Group REG,301-50PR-34635007482020-05-19
00850005066521The Harris Products GroupREG,723C-015LPM PANEL MT35007492020-05-19
00850005066538The Harris Products GroupREG,723C-050P PANEL MT35007502020-05-19
00850005066002The Harris Products GroupRegulator REG,3500-125-54030035002019-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628101620387OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620837OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620851OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101632625OhioOHIO MEDICAL, LLCCAN2026-05-18
00819601025837EscalonAirgas Therapeutics, LLCCAN2025-11-21
30653405988636Beamer AVEOConmed CorporationCAN2024-12-31
00810050863025MEDPAKLIFEPORT, LLCCAN2024-12-02
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G2981531871600100NAControl Devices, LLCCAN2024-08-08
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G298153187270050NAControl Devices, LLCCAN2024-08-08
G298153187270080NAControl Devices, LLCCAN2024-08-08
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G298153187280050NAControl Devices, LLCCAN2024-07-30
G298153187280080NAControl Devices, LLCCAN2024-07-30
G298202230NAControl Devices, LLCCAN2024-07-30
G298153187220010NAControl Devices, LLCCAN2024-07-26
G298153187220020NAControl Devices, LLCCAN2024-07-26