FDA.reportPublic FDA data

HAUSTED

Primary DI
M368H0678971
Brand
HAUSTED
Company
GF HEALTH PRODUCTS, INC.
Model
H067897
Device description
OXYFLEX DIFFUSION TRAY
Published
2025-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M368H0678972PackageHIBCC25In Commercial Distribution
M368H0678971PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Y-piece breathing circuit connector, single-use"A connecting device shaped in the form of a ""Y"" or ""T"" and designed to connect compatible components [e.g., the tubing and face mask or an endotracheal (ET) tube] to create a breathing circuit. In order to function this device will be part of a breathing circuit and will typically connect the inspiratory and expiratory sides at the point of entry into the patient. It will typically be used during anaesthesia and/or ventilation and is typically made of light plastic. This is a single-use device."

Contacts#

Phone, Email table
PhoneEmail
770-368-4700CS@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874956547Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
04719874956554Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
08697645010048Standard Breathing Circuit with Face Mask - ToddlerMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010079Standard Breathing Circuit with MouthpieceMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010116Standard Breathing Circuit with Face Mask - Adult MediumMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010550Standard Breathing Circuit with TrachMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
H66860701051Mizzy Comfort CushionKeystone IndustriesCAI2022-11-30
H66860701151Mizzy Comfort CushionKeystone IndustriesCAI2022-11-30
10080196082070Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983599Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983933Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983940Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983971Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196984176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2021-11-03
10080196984343Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2021-11-03
10190752108806Vital Signs™AirLife Finland OyCAI2021-07-06
10190752108820Vital Signs™VYAIRE MEDICAL, INC.CAI2021-07-06
10190752118416Vital Signs™AIRLIFECAI2020-02-20
10190752118430Vital Signs™AIRLIFECAI2020-02-20
10190752118485Vital Signs™AIRLIFECAI2020-02-20
10190752118843Vital Signs™AIRLIFECAI2020-02-20
10190752118850Vital Signs™AIRLIFECAI2020-02-20
10190752118867Vital Signs™AIRLIFECAI2020-02-20
10190752118874Vital Signs™AIRLIFECAI2020-02-20
10190752118881Vital Signs™AIRLIFECAI2020-02-20
10190752118898Vital Signs™AIRLIFECAI2020-02-20
10190752118904Vital Signs™AIRLIFECAI2020-02-20
10190752118911Vital Signs™AIRLIFECAI2020-02-20
10190752118928Vital Signs™AIRLIFECAI2020-02-20