FDA.reportPublic FDA data

BF

Primary DI
00026072021309
Brand
BF
Company
Allied Medical, LLC
Model
65401
Device description
O2 NUT AND STEM/PLASTIC
Published
2024-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00026072021309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00026072021309000260720213090260720213090026072021309

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen quick-connect coupling, maleA male connecting device used to connect to a medical gas pipeline system or other gas source allowing a user to rapidly connect and disconnect oxygen (O2) dependent devices to the O2 supply. It has safety features such as a specific mechanical mating pattern, colour coding and a dedicated tube diameter connection to prevent wrong connection. It is used to connect into an O2 terminal unit or female connector. It can be designed as a diameter-indexed safety system (DISS) connector or a non-interchangeable screw-threaded (NIST) connector.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119066872
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00026072011058Chemtron94-130134-10-00252016-09-15
00026072023723Chemtron3022-G34-10-00052016-09-12
00026072011225B&F643752016-08-24
00026072011232B&F643762016-08-24
00026072011249B&F643772016-08-24
00026072011256B&F643782016-08-24
00026072021439PC11-20-00112024-09-17
00026072026861ALLIED MEDICAL LLC01-90-310001-90-31002025-10-13
00026072026878ALLIED MEDICAL LLC01-90-3100-KIT01-90-3100-KIT2025-10-13
00026072026892ALLIED MEDICAL LLC01-90-392801-90-39282025-10-13
00026072026908ALLIED MEDICAL LLC01-90-3928-KIT 01-90-3928-KIT 2025-10-13
00026072001479EMLPEEP2024-05-28
00026072012161BF645502024-05-28
00026072020548BF64095-AHP2024-10-11
00026072022177EML599-0102024-05-28
00026072022184EML599-0302024-05-28
00026072022191EML599-1302024-05-28
00026072022207EML599-1402024-05-28
00026072022214EML599-1802024-05-28
00026072022238EML599-1902024-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109455Oxygen AccessorySunset Healthcare Solutions, Inc.CAN2026-07-23
00628101620387OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620837OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620851OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101632625OhioOHIO MEDICAL, LLCCAN2026-05-18
00848530108168RegulatorsSunset Healthcare Solutions, Inc.CAN2026-02-02
00848530108120RegulatorSunset Healthcare Solutions, Inc.CAN2026-01-26
00848530108151RegulatorSunset Healthcare Solutions, Inc.CAN2026-01-26
00848530107765Repair PartsSunset Healthcare Solutions, Inc.CAN2025-11-24
00848530107413React Regulator ValveSunset Healthcare Solutions, Inc.CAN2025-09-17
00848530106034Oxygen AccessorySunset Healthcare Solutions, Inc.CAN2025-06-03
00848530106041Oxygen AccessorySunset Healthcare Solutions, Inc.CAN2025-06-03
08592346893429VarimedGCE, s.r.o.CAN2025-03-17
08592346893436VarimedGCE, s.r.o.CAN2025-03-17
30653405988636Beamer AVEOConmed CorporationCAN2024-12-31
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