FDA.reportPublic FDA data

Respiratory Mechanics Combined Flow/CO2 Sensor – Neonatal

Primary DI
04049098007764
Brand
Respiratory Mechanics Combined Flow/CO2 Sensor – Neonatal
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
5957118
Published
2015-11-02
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
BZCCalculator, Pulmonary Function Data

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZCCalculator, Pulmonary Function DataAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049098007764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049098007764040490980077644049098007764

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit gas-flow sensor, reusableA device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a reusable device.

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
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