FDA.reportPublic FDA data

Resuscitation Face Mask Single Use Pre-Inflated Cushion Infant Size 1 Anatomical

Primary DI
05055931119876
Brand
Resuscitation Face Mask Single Use Pre-Inflated Cushion Infant Size 1 Anatomical
Company
FLEXICARE MEDICAL LIMITED
Model
NF-171-10U
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05055931119876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055931119876050559311198765055931119876

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055788767640Leg Bag Holder Extra Large00-0038U2020-03-25
05055788767671Leg Bag Holder Large00-0037U2020-03-25
05055788767701Leg Bag Holder Medium00-0036U2020-03-25
05055788767732Leg Bag Holder Small00-0035U2020-03-25
05055788787044Flexicare040-11-0000U2026-03-31
05055788787068Flexicare040-12-0130U2026-03-31
05055788787082Flexicare040-12-0140U2026-03-31
05055788787105Flexicare040-12-2130U2026-03-31
05055788787129Flexicare040-12-2135U2026-03-31
05055788787143Flexicare040-12-2140U2026-03-31
05055788791317Flexicare030-620/1U2024-03-13
05055931101963Maxineb Duo Filter Pad032-10-021U2020-03-27
05055931101970Maxineb Duo032-10-031U2020-03-27
05055931101994Maxineb Duo Nebulizer + Mouthpiece032-10-033U2020-03-27
05055931102014Maxineb Duo Nebulizer + Mouthpiece And Filter032-10-034U2020-03-27
05055931102038Maxineb Duo Filter032-10-035U2020-03-27
05055931102052Maxineb Duo Filter Master Case032-10-036U2020-03-27
05055931102076Maxineb Duo Nebulizer And Tubing032-10-037U2020-03-27
05055931102090Maxineb Duo Nebulizer + Mouthpiece And Tubing032-10-038U2020-03-27
05055931102113Maxineb Duo Nebulizer + Mouthpiece, Tubing And Filter032-10-039U2020-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
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09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10889483221662Performance Home MedicalSUNMED, LLCBYG2025-12-31
10889483227268BiFLo™SUNMED, LLCBYG2025-12-30
10889483227275BiFLo™SUNMED, LLCBYG2025-12-30
10889483223970AirLife™SUNMED, LLCBYG2025-12-19
10889483224151AirLife™SUNMED, LLCBYG2025-12-19
10889483224298DeVilbissSUNMED, LLCBYG2025-12-19
10889483224687AirLife™SUNMED, LLCBYG2025-12-19
10889483224168AirLife™SUNMED, LLCBYG2025-12-18
10197344011117HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011742HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011759HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011773HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344042203HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011599HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011605HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011612HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344009626HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06
10197344010646HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06
08697645018112ENDURE INDUSTRIESENDURE INDUSTRIESBYG2025-10-16
14026704648150HUDSON RCITELEFLEX INCORPORATEDBYG2025-07-03
14026704648235HUDSON RCITELEFLEX INCORPORATEDBYG2025-07-03