FDA.reportPublic FDA data

The Harris Products Group

Primary DI
00850005066019
Brand
The Harris Products Group
Company
J. W. HARRIS CO., INC.
Model
Regulator REG,HP702-053P-540C
Catalog number
3500525
Published
2019-11-12
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
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
00850005066019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005066019008500050660198500050660190850005066019

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
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
00850005066033The Harris Products GroupREG,301-OX15M-87035006032019-11-12
00850005066040The Harris Products GroupREG,301-N2015MC-91035006042019-11-12
00850005066057The Harris Products GroupREG,301C-50PR-910N2035006052019-11-12
00850005066095The Harris Products GroupREG,301-OX5L-54035006132019-11-12
00850005066101The Harris Products GroupREG,301-OX15CB-87035006142019-11-12
00850005066118The Harris Products GroupREG,301-50PR-870 0235006162019-11-12
00850005066132The Harris Products GroupREG,301-50PR-54035006172019-11-12
00850005066149The Harris Products GroupREG,301-OX15L-54035006192019-11-12
00850005066156The Harris Products GroupREG,25-2C T50P-54035006252019-11-12
00850005066163The Harris Products GroupREG,25-2C T50P-32635006262019-11-12
00850005066170The Harris Products GroupFLOW/REG,355-OX15MF540 FS10-570H35006292019-11-12
00850005066187The Harris Products GroupFLOW/REG,355-2OX15F-54035006302019-11-12
00850005066194The Harris Products GroupFLOW/REG,355-2OX15MF-87035006312019-11-12
00850005066200The Harris Products GroupFLOW/REG,355-OX15MF35006322019-11-12
00850005066248The Harris Products GroupFLWMTR,FME103 02-15 LPM DISS35006412019-11-12
00850005066255The Harris Products GroupFLWMTR,FME101 02-15 LPM W/O INLET35006422019-11-12
00850005066262The Harris Products GroupFLWMTR,FME104 02-15 LPM HT DISS35006432019-11-12

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Primary DI, Brand, Company table
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