FDA.reportPublic FDA data

Ventilator tubing support kit

Primary DI
04049098000260
Brand
Ventilator tubing support kit
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
MU18660
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAYSupport, Breathing Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001242000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001242000ISOLETTE INFANT INCUBATOR, MODEL C2HSHill-Rom Air-Shields2000-07-13FMZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049098000260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049098000260040490980002604049098000260

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18004372437info@draeger.com

Regulatory Flags#

DUNS number
788289952
Device count
1
Manufacturing date on label
true

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04049098000185Resuscitaire Birthing Room Warmer (WBR82)MU205122015-10-24
04049098000192TI500 Globetrotter Neonatal Transport SystemMU205082015-10-24
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