FDA.reportPublic FDA data

Atom Infant Warmer 103 AC120V

Primary DI
04942962616331
Brand
Atom Infant Warmer 103 AC120V
Company
ATOM MEDICAL CORPORATION
Model
61633
Catalog number
61633
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
04942962616331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04942962616331049429626163314942962616331

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth110Centimeter
Width84Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature18 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
690632047
Device count
1
Serial number
true
Manufacturing date on label
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

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