FDA.report

Respiratory Mechanics Combined Flow/CO2 Sensor – P

Primary DI
04049098007733
Brand
Respiratory Mechanics Combined Flow/CO2 Sensor – P
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
5957142
Published
2015-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BZKSpirometer, Monitoring (W/Wo Alarm)

Product Code Classifications

CodeDeviceSpecialtyClass
BZKSpirometer, Monitoring (W/Wo Alarm)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049098007733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049098007733040490980077334049098007733

GMDN Terms

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

Contacts

PhoneEmail
+18004372437info@draeger.com

Regulatory Flags

DUNS number
788289952
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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