FDA.reportPublic FDA data

Responsive Respiratory, Inc.

Primary DI
00851440007247
Brand
Responsive Respiratory, Inc.
Company
RESPONSIVE RESPIRATORY, INC.
Model
120-3010
Device description
Oxygen Regulator, 15 LPM CGA 540 w/ Barb
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
00851440007247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851440007247008514400072478514400072470851440007247

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
129132747
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851440007483Responsive Respiratory, Inc.200-01222025-12-13
00851440007841Responsive Respiratory, Inc.150-1145E2025-12-13
00851440007858Responsive Respiratory, Inc.150-1121E2025-12-13
00851440007865Responsive Respiratory, Inc.150-1500-56652025-12-13
00851440007803Responsive Respiratory, Inc.150-02402025-01-22
00851440007810Responsive Respiratory, Inc.150-02502025-01-22
00851440007827Responsive Respiratory, Inc.150-0246N2025-01-22
00851440007834Responsive Respiratory, Inc.150-01102025-01-22
00851440007629Responsive Respiratory220-36042024-08-01
00851440007636Responsive Respiratory220-36072024-08-01
00851440007643Responsive Respiratory220-36252024-08-01
00851440007650Responsive Respiratory220-37572024-08-01
00851440007667Responsive Respiratory220-30072024-08-01
00851440007681Responsive Respiratory220-30252024-08-01
00851440007698Responsive Respiratory220-30502024-08-01
00851440007704Responsive Respiratory220-35752024-08-01
00851440007711Responsive Respiratory220-3575-H2024-08-01
00851440007728Responsive Respiratory220-32102024-08-01
00851440007735Responsive Respiratory220-32152024-08-01
00851440007742Responsive Respiratory220-32212024-08-01

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
08592346893429VarimedGCE, s.r.o.CAN2025-03-17
08592346893436VarimedGCE, s.r.o.CAN2025-03-17
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