FDA.reportPublic FDA data

Flexicare

Primary DI
05055931117445
Brand
Flexicare
Company
FLEXICARE MEDICAL LIMITED
Model
038-53-535U
Device description
Neonatal Round Resuscitation Mask Size 01
Published
2024-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055931117445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055931117445050559311174455055931117445

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
504406273
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055788776246ProVu Video Stylet038-995-065U038-995-065U2025-05-30
05055788776260ProVu Video Stylet038-995-070U038-995-070U2025-05-30
05055788776284ProVu Video Stylet038-995-075U038-995-075U2025-05-30
05055788776307ProVu Video Stylet038-995-080U038-995-080U2025-05-30
05055788721499Flexicare040-836U2024-11-21
05055788721550Flexicare040-835U2024-11-21
05055788721802Flexicare040-831U2024-11-21
15055788722462BriteBlade Pro Evo Single-Use Fiber Optic Miller 4040-764U2024-08-07
15055788722486BriteBlade Pro Evo Single-Use Fiber Optic Miller 3040-763U2024-08-07
15055788722509BriteBlade Pro Evo Single-Use Fiber Optic Miller 2040-762U2024-08-07
15055788722523BriteBlade Pro Evo Single-Use Fiber Optic Miller 1040-761U2024-08-07
15055788722561BriteBlade Pro Evo Single-Use Fiber Optic Mac 4040-754U2024-08-07
15055788722585BriteBlade Pro Evo Single-Use Fiber Optic Mac 2040-753U2024-08-07
15055788722608BriteBlade Pro Evo Single-Use Fiber Optic Mac 1040-752U2024-08-07
15055788722622BriteBlade Pro Evo Single-Use Fiber Optic Mac 1040-751U2024-08-07
05055931127888Flexicare032-10-180LU2024-07-17
05055931127895Flexicare032-10-181LU2024-07-17
05055931127901Flexicare032-10-182LU2024-07-17
05055931127918Flexicare010-762LU2024-07-17
05055931104162ProVu040-08-0420U2024-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501348OXYGEN MASK Single Use Size 4 with nebulizerASSOMEDIKA, OOOBYG2026-05-26
04816415501355OXYGEN MASK Single Use Size 4 with bagASSOMEDIKA, OOOBYG2026-05-26
04816415501362OXYGEN MASK Single Use Size 4ASSOMEDIKA, OOOBYG2026-05-26
06923980112577MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112584MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112591MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112607MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112690MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-26
06923980112553MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112560MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112645MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112652MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112669MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112706MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
06923980112713MindrayGaleMed Xiamen Co., Ltd.BYG2026-05-25
07045432120462Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120479Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120486Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120493Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120509Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
20885632467407HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
20885632467414HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
20885632467469HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
07045432115987The BAG Mask size 1Laerdal Medical ASBYG2026-01-14
07045432115994The BAG Mask size 2 Laerdal Medical ASBYG2026-01-14
07045432116007The BAG Mask size 3 Laerdal Medical ASBYG2026-01-14
07045432116014The BAG Mask size 4Laerdal Medical ASBYG2026-01-14
07045432116021The BAG Mask size 5Laerdal Medical ASBYG2026-01-14
20889483221669Performance Home MedicalSUNMED, LLCBYG2025-12-31
20889483227265BiFLo™SUNMED, LLCBYG2025-12-30