FDA.report

BF

Primary DI
40026072023462
Brand
BF
Company
Allied Medical, LLC
Model
64059-AHP
Device description
MASK,ADULT,NON-REB,W/O VENT,
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
BYGMask, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40026072023462PackageGS150In Commercial Distribution
00026072023464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4002607202346240026072023462
00026072023464000260720234640260720234640026072023464

GMDN Terms

TermDefinition
Non-rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. 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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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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