FDA.reportPublic FDA data

Protekt Regulator

Primary DI
05060488573248
Brand
Protekt Regulator
Company
PROACTIVE MEDICAL PRODUCTS, LLC
Model
PMREG04D
Catalog number
PMREG04D
Device description
Oxygen Regulator, Pediatric, 0-4 LPM Full Size, CGA 540, Diss Outlet - Master Carton - Qty 20
Published
2022-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
05060488573248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488573248050604885732485060488573248

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen therapy conserving regulatorA device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cylinder, and is used to regulate the high pressure of the supply to a safe working pressure which is delivered to the patient requiring oxygen therapy and ensuring that the prescribed (set/dialed) dosage of O2 is maintained at an accurate level. It acts both as a pressure reduction device and an O2 saving device. Commonly known as an oxygen conserving regulator it may be designed to provide a bolus of O2 to the patient by metering the gas over the normal inspiration/expiration phases, thus conserving it.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height11.5Inch
Length7.5Inch
Width16Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 855 237 7622sales@proactivemedical.com

Regulatory Flags#

DUNS number
078582655
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05061105057455Protekt VX 5000PMVSM5000PMVSM50002025-12-18
05060488573293Protekt PartsPP-AHDAASMK3LFTPP-AHDAASMK3LFT2022-11-18
05060488573309Protekt PartsPP-AHDAASMK3RTPP-AHDAASMK3RT2022-11-18
05060488573316Protekt PartsPP-AHFAASMK3LFTPP-AHFAASMK3LFT2022-11-18
05060488573323Protekt PartsPP-AHFAASMK3RTPP-AHFAASMK3RT2022-11-18
05060488572401Protekt LiftPL400HPL400H2022-05-11
05060488570902Procure Nebulizer002-102785002-1027852020-01-01
05060488570926Procure Blood Pressure Monitor, Digital, Auto Inflate w/ Batteries002-102738002-1027382020-01-01
05060488570162Protekt Aire94001940012016-08-12
05060488570179Protekt Aire94003940032016-08-12
05060488570186Protekt Aire94004940042016-08-12
05060488570452Protekt Aire Replacement Pump80091800912016-08-12
05060488570490Protekt Aire Replacement Mattress80032800322016-08-12
05060488570506Protekt Aire Replacement Mattress80042800422016-08-12
05060488570544Protekt Aire Replacement Mattress80082800822016-08-12
05060488570551Protekt Aire Replacement Mattress80087800872016-08-12
05060488570728Protekt Aire83500835002018-03-07
05060488570735Protekt Aire83600836002018-03-07
05060488570742Protekt Aire84600846002018-03-07
05060488570773Protekt Aire81090-42B81090-42B2018-03-07

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
G298153187300010NAControl Devices, LLCCAN2024-08-09
G2983429110200B080NAControl Devices, LLCCAN2024-08-09
G2981531871600100NAControl Devices, LLCCAN2024-08-08
G298153187160050NAControl Devices, LLCCAN2024-08-08
G298153187270020NAControl Devices, LLCCAN2024-08-08
G298153187270040NAControl Devices, LLCCAN2024-08-08
G298153187270050NAControl Devices, LLCCAN2024-08-08
G298153187270080NAControl Devices, LLCCAN2024-08-08
G298153187280010NAControl Devices, LLCCAN2024-08-08
G298153187280020NAControl Devices, LLCCAN2024-08-08
G298153187280030NAControl Devices, LLCCAN2024-08-08
G298153187280040NAControl Devices, LLCCAN2024-08-08
G2982108080NAControl Devices, LLCCAN2024-08-08
G2982108150NAControl Devices, LLCCAN2024-08-08
G2982108250NAControl Devices, LLCCAN2024-08-08
G2982212200NAControl Devices, LLCCAN2024-08-08
G2982216200NAControl Devices, LLCCAN2024-08-08
G2982217200NAControl Devices, LLCCAN2024-08-08
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