FDA.reportPublic FDA data

Giraffe Incubator Carestation

Primary DI
00840682116855
Brand
Giraffe Incubator Carestation
Company
Datex-Ohmeda, Inc.
Model
CS1
Device description
GIRAFFE INCUBATOR CARESTATION CS1
Published
2016-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FMZINCUBATOR, NEONATAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMZIncubator, NeonatalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152809000
K213553000
K251663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152809000Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc.2015-12-31FMZ
K213553000Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.2022-03-02FMZ
K251663000Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.2025-10-22FMZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682116855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682116855008406821168558406821168550840682116855

GMDN Terms#

Term, Definition table
TermDefinition
Conventional infant incubatorA mains electricity (AC-powered) unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature. It typically consists of a clear removable plastic hood with a mattress. It typically includes a means to warm the infant such as providing heated air (either by natural flow or forced) or through a warm water mattress; temperature controls that work automatically either by measuring the air temperature or through a temperature sensor attached to the infant skin; and humidity controls. The device is intended to remain in a hospital ward.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118933716
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682143660Panda EU In-Bed ScalePS EU12022-12-08
00840682143714Giraffe EU In-Bed ScaleGS EU12022-12-08
00840682116534BiliSoft Phototherapy SystemBI22016-06-24
00840682116558BiliSoft Phototherapy SystemBI32016-06-24
00840682116565BiliSoft Phototherapy SystemBI12016-06-24
00840682152709Pandai-Res Warmer 1.02020-06-11
00840682103923GiraffeWarmer2016-06-24
00195278358363GIRAFFE PANDA DISPOSABLE SKIN TEMPERATURENA2021-11-10
00840682103909PandaWall Mount Warmer2016-06-24
00840682103916PandaFreestanding Warmer2016-06-24
00840682116862Giraffe OmniBed CarestationCS12016-06-24
00840682142731NoviiPOD 107-PT-0032019-01-29
05060433670091NOVII INTERFACE CABLEGE FECG105-PT-1022016-09-12
05060433670114NOVII INTERFACE CABLEGE MECG105-PT-1042016-09-12
05060433670138NOVII INTERFACE CABLEGE UA105-PT-1062016-09-12
00195278115171NOVIINOVII+ POD2024-06-03
00195278212313NOVIINOVII+ INTERFACE2024-06-03
00840682143677Giraffe In-Bed ScaleGS12022-12-08
00840682143684IV POLE ASSY 12 IN12 Inch IV10217-5378-8002022-12-06
00840682143691ROTATING IV POLERotating IV16600-0851-8002022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675641308Babyleo TN500Drägerwerk AG & Co. KGaAFMZ2026-03-23
10889483577363AirLife™AirLife Finland OyFMZ2025-03-26
10889483577370AirLife™AirLife Finland OyFMZ2025-03-26
20889483577360AirLife™AirLife Finland OyFMZ2025-03-26
20889483577377AirLife™AirLife Finland OyFMZ2025-03-26
10889483577387AirLife™AirLife Finland OyFMZ2025-03-26
B510A31860ADVANCED NEONATAL INCUBATORADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
B510A31861ADVANCED NEONATAL INCUBATORADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
B510A4051ADVANCED INFANT WARMERADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
04942962610858V-2200 Infant Incubator ATOM MEDICAL CORPORATIONFMZ2024-10-29
04942962616102Neo-Servo i Atom Infant Incubator Model 102ATOM MEDICAL CORPORATIONFMZ2024-10-29
04942962674065V-2100G Advanced Infant Incubator ATOM MEDICAL CORPORATIONFMZ2024-10-29
04048675436607Babyleo TN500Drägerwerk AG & Co. KGaAFMZ2024-03-09
00860007476310ATOM Medical USA, Disposable ProbeAtom Medical Usa, LLCFMZ2022-02-08
00195278358363GIRAFFE PANDA DISPOSABLE SKIN TEMPERATUREDatex-Ohmeda, Inc.FMZ2021-11-10
00763000374716Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21
00763000374723Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21
10190752179608AirlifeAirLife Finland OyFMZ2021-02-26
10190752179615AirlifeAirLife Finland OyFMZ2021-02-26
20190752179605AirlifeVYAIRE MEDICAL, INC.FMZ2021-02-26
70190752179617AirlifeVYAIRE MEDICAL, INC.FMZ2021-02-26
10190752179622AirlifeAirLife Finland OyFMZ2021-02-26
10190752106130Multi-Link™AirLife Finland OyFMZ2021-01-13
10190752106147Multi-Link™AirLife Finland OyFMZ2021-01-13
20190752106137Multi-Link™Vyaire Medical OyFMZ2021-01-13
20190752106144Multi-Link™Vyaire Medical OyFMZ2021-01-13
10190752106161Multi-Link™AirLife Finland OyFMZ2021-01-13
00643169912199Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2019-06-08
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2019-06-08