FDA.report

BF

Primary DI
40026072023752
Brand
BF
Company
Allied Medical, LLC
Model
HCS64184
Device description
FACE MASK W/1 WAY VAL, FIL CS
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
40026072023752PackageGS112In Commercial Distribution
00026072023754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4002607202375240026072023752
00026072023754000260720237540260720237540026072023754

GMDN Terms

TermDefinition
Cardiopulmonary resuscitation mask, single-useA flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. 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

Other Devices From This Company

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00026072012406PC11-02-00382024-11-05
00026072012536PC11-02-10302024-11-05
00026072012550PC11-02-50412024-11-05
00026072012567PC11-02-50432024-11-05
00026072012604PC11-10-00072024-11-05
00026072012611PC11-10-00082024-11-05
00026072012659PC11-10-00182024-11-05
00026072012680PC11-10-00322024-11-05
00026072012697PC11-10-00332024-11-05
00026072012741PC11-10-00432024-11-05
00026072012789PC11-10-00482024-11-05
00026072013977PC11-01-00052024-11-05
00026072013991PC11-01-00092024-11-05
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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