FDA.reportPublic FDA data

Puritan Bennett

Primary DI
20884521210933
Brand
Puritan Bennett
Company
Covidien LP
Model
10047078
Device description
Proximal Flow Sensor Neonatal
Published
2023-02-03
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
10884521210936PackageGS110In Commercial Distribution
20884521210933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452121093610884521210936
2088452121093320884521210933

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit multi-parameter sensorA device intended to be connected to a breathing circuit to transduce signals from respiratory gases to enable a parent device receiving the signals to measure multiple parameters of the respiratory gases (e.g., flow, temperature). It is in the form of a transducer connected to the parent monitoring/measuring device; the parent device will typically display the parameters it receives and may respond by making control adjustments. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521620193Shiley18775S2017-04-18
10884521620209Shiley18780S2017-01-06
10884521543805SigniaSIGADAPTSTND2017-08-08
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

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