FDA.reportPublic FDA data

Respiratory Mechanics Combined Flow/CO2 Sensor – Pediatric

Primary DI
04049098007733
Brand
Respiratory Mechanics Combined Flow/CO2 Sensor – Pediatric
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZKSpirometer, Monitoring (W/Wo Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZKSpirometer, Monitoring (W/Wo Alarm)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049098007733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049098007733040490980077334049098007733

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049098095778SHIP UNIT M300+MS336482025-02-19
04049098053785Infinity etCO2 SmartPod57407202015-10-24
04049098061858Disposable Mechanical Ventilation CircuitMU047712025-12-10
04049098041829Disposable Mechanical Ventilation CircuitMU047712025-12-10
04049098000406Breathing hose for Resuscitaire with AutoBreath, disposable, 25 pcs.MU108412015-10-24
04048675673408Gateway Software Server VF9.0.1MS405452025-02-19
04048675762256Gateway Software Server VF9.1.137347182025-02-19
04048675777762Gateway Software Server VF9.1.237363762025-02-19
04048675780212Infinity R50-S RecorderMS412172025-02-19
04049098001519Infinity M300 Bedside ChargerMS295582025-02-19
04049098007061Infinity Gateway USB DongleMS117002025-02-19
04049098095730Infinity M300+MS339502025-02-19
04049098096423SHP EXC M300+MS336592025-02-19
04049098099264S/W SUB VF9.0 GatewayMS400462025-02-19
04049098099608Gateway Software Server VF9.0MS400482025-02-19
04049098001878Infinity CentralStation Wide (confi)MS268002015-10-24
04049098000185Resuscitaire Birthing Room Warmer (WBR82)MU205122015-10-24
04049098000192TI500 Globetrotter Neonatal Transport SystemMU205082015-10-24
04049098000215Resuscitaire Radiant Warmer (RW82, RW82 VHA)MU205032015-10-24
04049098000413Restraint strap, replacement, carton of 10MU060112015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyBZK2026-04-15
00851540007161ExSpiron Pediatric PadSetsSenzime AB (Publ.)BZK2024-01-25
05065016557004KoKoKOKO PFT LTDBZK2023-08-01
05065016557011KoKoKOKO PFT LTDBZK2023-08-01
05065016557028KoKoKOKO PFT LTDBZK2023-08-01
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyBZK2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyBZK2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyBZK2023-04-19
00195278524089NAGE Healthcare Finland OyBZK2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyBZK2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyBZK2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyBZK2022-05-13
00840682104135NAGE Healthcare Finland OyBZK2022-03-07
00840682104302NAGE Healthcare Finland OyBZK2022-03-07
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B005002980AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
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B005003020AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003030AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
B005003050AincA®ANESTHESIA ASSOCIATES, INC.BZK2021-03-31
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