FDA.reportPublic FDA data

Responsive Respiratory, Inc.

Primary DI
00851440007537
Brand
Responsive Respiratory, Inc.
Company
RESPONSIVE RESPIRATORY, INC.
Model
200-0172
Device description
Cylinder Wrench with Chain, CGA 870, Plastic, 2 Yoke Washers 10/pack
Published
2023-06-09
Public version status
Update
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
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851440007537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851440007537008514400075378514400075370851440007537

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration kit, non-sterileA collection of non-sterile devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851440007704Responsive Respiratory220-35752024-08-01
00851440007711Responsive Respiratory220-3575-H2024-08-01
00851440007575Responsive Respiratory, Inc.220-35802026-07-22
00851440007902Responsive Respiratory, Inc.150-1100E2026-07-22
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
00851440007728Responsive Respiratory220-32102024-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530087142Respiratory AccessorySunset Healthcare Solutions, Inc.BYX2025-11-19
00848530070236CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00848530070281CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00789091681564Oxygen TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681595CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681601CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00848530089375Suction KitSunset Healthcare Solutions, Inc.BYX2025-04-15
00848530094232AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094256AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094263AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094270AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094294AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094317AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094331AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094348AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094355AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094362AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094379AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094386AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094393AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094409AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094416AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094423AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094430AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094447AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094454AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094461AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094478AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094485AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094492AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07