FDA.report

BF

Primary DI
40026072023356
Brand
BF
Company
Allied Medical, LLC
Model
33604
Device description
PED CANNULA W/7' TUBE
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40026072023356PackageGS150In Commercial Distribution
00026072023358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4002607202335640026072023356
00026072023358000260720233580260720233580026072023358

GMDN Terms

TermDefinition
Nasal oxygen cannula, basicA semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119066872
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00026072014103PC11-01-00712024-11-05
00026072014134PC11-01-01132024-11-05
00026072014257PC11-03-00082024-11-05
00026072014356PC11-10-00852024-11-05
00026072014363PC11-10-00862024-11-05
00026072014387PC11-13-00072024-11-05
00026072014752PC12-01-42002024-11-05

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Primary DIBrandCompanyProduct codePublished
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20885632467391HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
20885632467445HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
20885632467452HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
15694311111894Nox Nasal Pressure Cannula with FilterNox Medical ehf.CAT2026-01-28
00850077887017AERIS Airway - MSA Luer KitAirway Innovations, Inc.CAT2026-01-08
00850077887048AERIS Airway - Male Luer KitAirway Innovations, Inc.CAT2026-01-08
00850077887079AERIS Airway - Female Luer KitAirway Innovations, Inc.CAT2026-01-08
20889483223014Montgomery DMESUNMED, LLCCAT2025-12-30
20197344162694CARINGMEDLINE INDUSTRIES, INC.CAT2025-11-27
20197344158406HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158413HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158420HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158437HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158444HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
20197344158451HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
05030267165322I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULTIntersurgical IncorporatedCAT2025-09-23
05030267165346I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULTIntersurgical IncorporatedCAT2025-09-23
05030267165360HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULTIntersurgical IncorporatedCAT2025-09-23
20197344158468HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161161MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161178MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
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20197344161192MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161208MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161215MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161222MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161239MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344155061MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21