FDA.reportPublic FDA data

Flow Sensor

Primary DI
00884838014374
Brand
Flow Sensor
Company
Respironics Novametrix, LLC
Model
9767-00
Catalog number
9767-00
Device description
CO2/Flow Sensor Adult
Published
2020-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
30884838014375PackageGS110In Commercial Distribution
00884838014374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088483801437530884838014375
00884838014374008848380143748848380143740884838014374

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit gas-sampling/monitoring setA collection of non-sterile devices intended to be integrated within a breathing circuit to enable interface of gases between the breathing circuit and a respiratory monitoring device for sampling the patient's expired gas for measurements of pressure, flow and/or gas analysis [e.g., end-tidal carbon dioxide (EtCO2) concentration]. It includes both a tube/mask breathing circuit connector with sampling ports (sometimes referred to as a spirometry sensor) and gas-sampling/monitoring respiratory tubing; no electronic devices are included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)744-2500Respironics.Service@philips.com

Regulatory Flags#

DUNS number
093608594
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838104723Airway Adapters114946611494662023-11-15
00884838104730Airway Adapters114933911493392023-11-15
00884838104761Airway Adapters114938111493812023-11-15
00884838104778Airway Adapter114938311493832023-11-15
00884838104785Airway Adapters114938611493862023-11-15
00884838104792Airway Adapters114944811494482023-11-15
00884838104884LoFlo Accessories114948011494802023-11-15
00884838104891LoFlo Accessories114948211494822023-11-15
00884838104907LoFlo Accessories114948311494832023-11-15
00884838104938LoFlo Accessories114937911493792023-11-15
00884838104945LoFlo Accessories114948811494882023-11-15
00884838104952Airway Adapters114948911494892023-11-15
00884838104969Airway Adapters114949011494902023-11-15
00884838104976Airway Adapters114949111494912023-11-15
00884838104983Airway Adapters114949211494922023-11-15
00884838105584Flow Sensor114990311499032023-11-15
00884838105607Flow Sensor114990511499052023-11-15
00884838105614Airway Adapters114994811499482023-11-15
00884838105621Airway Adapters114994211499422023-11-15
00884838104662Capnostat 5 114932111493212023-11-14

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
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
04036616001809Flow sensorHoneywell Healthcare Solutions GmbHBXP2016-09-22
04049098007740Respiratory Mechanics Flow Sensor – Adult/PediatricDRAEGER MEDICAL SYSTEMS, INC.BXP2015-11-02