FDA.reportPublic FDA data

Face Mask For Infant(20 pcs/box)

Primary DI
04942962601467
Brand
Face Mask For Infant(20 pcs/box)
Company
ATOM MEDICAL CORPORATION
Model
60146
Catalog number
60146
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
14942962601464PackageGS120In Commercial Distribution
04942962601467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1494296260146414942962601464
04942962601467049429626014674942962601467

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+81 488533661hitoshi.hayashi@atomed.co.jp

Regulatory Flags#

DUNS number
690632047
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04942962613057V-707 with Power Pack(100-120V)61305613052016-09-21
04942962610858V-2200 Infant Incubator 61085610852024-10-29
04942962616102Neo-Servo i Atom Infant Incubator Model 10261610616102024-10-29
04942962674065V-2100G Advanced Infant Incubator 67406674062024-10-29
04942962603058Oxygen Sensor For V-80860305603052016-09-21
04942962603171Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR60317603172016-09-21
04942962608619Semi-Iris Access Port Cover(20 pcs/pkg)60861608612016-09-21
04942962615228V-808 Main Unit Only(120 V)61522615222016-09-21
04942962603706BILI-THERAPY Pad Type60370603702016-09-21
04942962603713Pad(L) For BILI-THERAPY Pad Type60371603712016-09-21
04942962603720Pad(S) For BILI-THERAPY Pad Type60372603722016-09-21
04942962603737Pad Cover(L) For BILI-THERAPY Pad Type(50 pcs/box)60373603732016-09-21
04942962603744Pad Cover(S) For BILI-THERAPY Pad Type(50 pcs/box)60374603742016-09-21
04942962603874Neo Cot HL Stand60387603872016-09-21
04942962261227Mattress Sheet for Neo Cot(5 pcs/pkg)26122261222016-10-28
04942962603218Mattress Sheets(5 pcs/pkg)60321603212016-09-21
04942962603867Patient Circuit60386603862015-09-08
04942962602983Test Bag, 50mL60298602982015-10-23
04942962603553Dispo Liner, 500mL For S401D, Suction Canister(30 pcs/box)60355603552016-09-21
04942962603621Resusci Flow Rail mounting type60362603622016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
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04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
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09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
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10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011599HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
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