FDA.report

EM

Primary DI
00026072022351
Brand
EM
Company
Allied Medical, LLC
Model
L099-000
Device description
CUFFED MASK, INFANT
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
00026072022351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00026072022351000260720223510260720223510026072022351

GMDN Terms

TermDefinition
Anaesthesia face mask, reusableA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a reusable 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

Primary DIBrandModelCatalogPublished
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
20889483227272BiFLo™SUNMED, LLCBYG2025-12-30
20889483223977AirLife™SUNMED, LLCBYG2025-12-19
20889483224158AirLife™SUNMED, LLCBYG2025-12-19
20889483224295DeVilbissSUNMED, LLCBYG2025-12-19
20889483224684AirLife™SUNMED, LLCBYG2025-12-19
20889483224165AirLife™SUNMED, LLCBYG2025-12-18
20197344011114HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
20197344011749HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
20197344011756HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
20197344011770HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
20197344042200HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
B0026300RescuerB.L.S. Systems LimitedBYG2025-11-24
B00263050RescuerB.L.S. Systems LimitedBYG2025-11-24
20197344011589HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
20197344011596HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14