FDA.report

SpiroLife

Primary DI
04048675005612
Brand
SpiroLife
Company
Drägerwerk AG & Co. KGaA
Model
MK01900
Published
2022-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BXPTransducer, Gas Flow

Product Code Classifications

CodeDeviceSpecialtyClass
BXPTransducer, Gas FlowAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048675005612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048675005612040486750056124048675005612

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

Regulatory Flags

DUNS number
315578914
Device count
1
DM exempt
false
Premarket exempt
true
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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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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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
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
10884521139855Puritan BennettCovidien LPBXP2021-04-15
00884838014114RespironicsRESPIRONICS NOVAMETRIX, LLCBXP2020-09-14
00884838014121RespironicsRESPIRONICS NOVAMETRIX, LLCBXP2020-09-14
00884838014138RespironicsRESPIRONICS NOVAMETRIX, LLCBXP2020-09-14
00884838014145RespironicsRESPIRONICS NOVAMETRIX, LLCBXP2020-09-14
00884838014152RespironicsRESPIRONICS NOVAMETRIX, LLCBXP2020-09-14
00884838014350RespironicsRESPIRONICS NOVAMETRIX, LLCBXP2020-09-14
00884838014367RespironicsRESPIRONICS NOVAMETRIX, LLCBXP2020-09-14
00884838014374RespironicsRESPIRONICS 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
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04049098007740Respiratory Mechanics Flow Sensor – Adult/PediatriDRAEGER MEDICAL SYSTEMS, INC.BXP2015-11-02