FDA.reportPublic FDA data

SpO2 Unit(Masimo)

Primary DI
04942962616256
Brand
SpO2 Unit(Masimo)
Company
ATOM MEDICAL CORPORATION
Model
61625
Catalog number
61625
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMTWarmer, Infant Radiant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMTWarmer, Infant RadiantGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04942962616256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04942962616256049429626162564942962616256

GMDN Terms#

Term, Definition table
TermDefinition
Open infant incubatorA mains electricity (AC-powered) unit that functions similar to a standard infant incubator but is open, having low side walls and no top enclosure, giving instant access to the infant. Such infants are not premature but suffer from disorders where intensive care is required. This device is equipped with overhead heating lamp(s), oxygen therapy flowmeter, gas mixer, suction system, facilities for infusion pumps, and other equipment. The main difference between this device and a closed infant incubator is the inability of this device to regulate the oxygen environment surrounding the occupant.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
690632047
Device count
1
DM exempt
true
Serial number
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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20889483587888AirLife™AirLife Finland OyFMT2025-03-26
20889483587901AirLife™AirLife Finland OyFMT2025-03-26
10889483587959AirLife™AirLife Finland OyFMT2025-03-26
04048675436607Babyleo TN500Drägerwerk AG & Co. KGaAFMT2024-03-09
00865648000313NuBorne Infant WarmerINTERNATIONAL BIOMEDICAL, LTD.FMT2023-06-20
04049098099042Babyroo TN300 Infant Radiant WarmerDRAEGER MEDICAL SYSTEMS, INC.FMT2023-06-08
00749756379205DeRoyalDEROYAL INDUSTRIES, INC.FMT2023-02-06
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00860007476310ATOM Medical USA, Disposable ProbeAtom Medical Usa, LLCFMT2022-02-08
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50749756927555DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
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50749756927579DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756983988DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
50749756995561DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-05-07
00749756372305DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-03-22
50749756372300DeRoyalDEROYAL INDUSTRIES, INC.FMT2021-03-22
10190752181236Airlife™AirLife Finland OyFMT2021-03-09
10190752181199Airlife™AirLife Finland OyFMT2021-03-05
20190752181196Airlife™VYAIRE MEDICAL, INC.FMT2021-03-05