FDA.reportPublic FDA data

Flow sensor

Primary DI
04036616001809
Brand
Flow sensor
Company
Honeywell Healthcare Solutions GmbH
Model
SpiroQuant A+
Catalog number
1000470
Device description
Flow sensor SpiroQuant A+
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BXPTransducer, Gas Flow

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXPTransducer, Gas FlowAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04036616001809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04036616001809040366160018094036616001809

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height40Millimeter
Length110Millimeter
Width140Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
330943838
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04036616010948Oxygen SensorOOMLF102-M3E10026032020-03-03
04036616013895Oxygen SensorOOM113-ME10029542025-11-12
04036616010856Oxygen SensorOOMLF111-HE10025382025-04-28
04036616013871Oxygen SensorOOMLF204-DE10029522025-04-28
04036616000581Disposable SensorDA-2221-1 BCI08-00-01232016-09-22
04036616007146Disposable SensorDA-2221-1 OEM BCI08-00-03232016-09-22
04036616010207Disposable sensorDA-2203-1 Nihon Kohden US10023242016-09-22
04036616001939SoftTip largeR-3212-31 Nellcor06-00-07092016-09-22
04036616001946SoftTip largeR-3222-12 BCI06-00-05842016-09-22
04036616002066SoftTip largeR-3512-40 Datex06-00-07272016-09-22
04036616002073SoftTip largeR-3512-9 Datex06-00-07662016-09-22
04036616002127SoftTip smallRS-2182-3 Minolta06-00-05912016-09-22
04036616002158SoftTip smallRS-2412 HP/Philips06-00-07262016-09-22
04036616002202SoftTip smallRS-3222-12 BCI06-00-05832016-09-22
04036616002257SoftTip smallRS-3412 Ohmeda06-00-07162016-09-22
04036616002264SoftTip smallRS-3412-10 Ohmeda06-00-08222016-09-22
04036616002295SoftTip smallRS-3512-40 Datex06-00-07292016-09-22
04036616002301SoftTip smallRS-3512-9 Datex06-00-08152016-09-22
04036616002349SoftTip® mediumRM-2182-3 Minolta06-00-13612016-09-22
04036616002370SoftTip® mediumRM-2412 HP/Phillips06-00-13642016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838105584Flow SensorRespironics Novametrix, LLCBXP2023-11-15
00884838105607Flow SensorRespironics Novametrix, LLCBXP2023-11-15
30884838105585RespironicsRespironics Novametrix, LLCBXP2023-11-15
30884838105608RespironicsRespironics Novametrix, LLCBXP2023-11-15
07640142190479Spiro-SP TrueFlow SensorNDD Medizintechnik AGBXP2023-06-23
20884521210933Puritan BennettCovidien LPBXP2023-02-03
10884521210936Puritan BennettCovidien LPBXP2023-02-03
04048675000099Neonatal flow sensor ISO15Drägerwerk AG & Co. KGaABXP2022-04-08
04048675005612SpiroLifeDrägerwerk AG & Co. KGaABXP2022-04-08
04048675448853Neonatal flow sensor insertDrägerwerk AG & Co. KGaABXP2022-04-08
04048675448860Spirolog Flow SensorDrägerwerk AG & Co. KGaABXP2022-04-08
04048675448938Infinity ID Flow SensorDrägerwerk AG & Co. KGaABXP2022-04-08
20884521139852Puritan BennettCovidien LPBXP2021-04-15
10884521139855Puritan BennettCovidien LPBXP2021-04-15
00884838014114Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014121Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014138Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014145Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014152Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014350Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014367Flow SensorRespironics Novametrix, LLCBXP2020-09-14
00884838014374Flow SensorRespironics Novametrix, LLCBXP2020-09-14
06944904096766Respiratory Mech mod,w/accssryShenzhen Mindray Bio-Medical Electronics Co., Ltd.BXP2020-05-07
06420099000554M9256, SpiroSafe Disposable Flow TransducerMedikro OyBXP2018-07-13
06420099000561M9256, SpiroSafe Disposable Flow TransducerMedikro OyBXP2018-07-13
04049098007740Respiratory Mechanics Flow Sensor – Adult/PediatricDRAEGER MEDICAL SYSTEMS, INC.BXP2015-11-02