FDA.reportPublic FDA data

MX40 Masimo Leadsets and Adapters

Primary DI
00884838090101
Brand
MX40 Masimo Leadsets and Adapters
Company
Philips Medical Systems Hsg
Model
ECG 5L Grabber, AAMI, Masimo SpO2 , Tele
Catalog number
989803202411
Device description
"ECG 5L Grabber, AAMI, Masimo SpO2, Tele. MX40 Patient Cable consists of 5-wire ECG lead set with integrated 8-pin Masimo SET SpO2 connector cable. Grabber leads, AAMI color coded (colored lead wires). Reusable. Cable length = 85 cm (33.5""). 1 Sales unit = 1 cable."
Published
2020-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838090101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838090101008848380901018848380901010884838090101

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-40 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
790605856
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884838097173Nasal Alar SpO2 SensorNasal Alar SpO2 Sensor FAST Only, 20/CS9898032053812020-04-03
20884838097548Nasal Alar SpO2 SensorNasal Alar SpO2 Sensor MLT CPTL, 24/CS9898032053912020-04-03
20884838097593Nasal Alar SpO2 SensorTri-anim, Nasal SpO2 Sensor, 24/CS9898032054012020-04-03
20884838015245HeartStartExternal Paddles Water ResistantM3543A2014-09-24
00884838090088MX40 Masimo Leadsets and AdaptersMX40 Adapter 5-Lead + Masimo SpO29898032023812022-05-23
00884838090095MX40 Masimo Leadsets and AdaptersMX40 Adapter Masimo SpO2-only9898032023912022-05-23
00884838090118MX40 Masimo Leadsets and AdaptersECG 5L Grabber, IEC, Masimo SpO2 , Tele9898032024212020-04-21
00884838091276MX40 Masimo Leadsets and AdaptersMX40 Adapter 6-Lead + Masimo SpO29898032042912020-04-21
00884838013360ECG ElectrodesCBL ECG 3LEAD GRABBER, AAMI + SPO2, TELE9898031718112017-07-13
00884838013377ECG ElectrodesCBL ECG 5 LEAD SNAPS, AAMI, TELE9898031718212016-10-13
00884838013384ECG ElectrodesCBL ECG 5 LEAD GRABBER, AAMI, TELE9898031718312016-09-27
00884838013391ECG ElectrodesCBL ECG 5 LEAD SNAPS, AAMI + SPO2, TELE9898031718412016-09-27
00884838013407ECG ElectrodesCBL ECG 5LEAD GRABBER, AAMI + SPO2, TELE9898031718512016-09-27
00884838013414ECG ElectrodesCBL ECG 6 LEAD GRABBER, AAMI, TELE9898031718612017-07-27
20884838013517ECG ElectrodesCBL ECG 5 LEAD GRABBER IEC, SPU, TELE9898031721312020-03-25
20884838013494ECG ElectrodesCBL ECG 5 LEAD GRABBER, AAMI, SPU, TELE9898031720312016-10-12
00884838013421ECG ElectrodesCBL ECG 6LEAD GRABBER, AAMI + SPO2, TELE9898031718712016-11-22
00884838013445ECG ElectrodesCBL ECG 3 LEAD GRABBER, IEC + SPO2, TELE9898031719112016-11-29
00884838013452ECG ElectrodesCBL ECG 5 LEAD GRABBER, IEC, TELE9898031719312016-10-13
00884838013469ECG ElectrodesCBL ECG 5 LEAD GRABBER, IEC + SPO2, TELE9898031719512016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
G662ME590032R1MaguireMaguire Enterprises, Inc.DSA2026-08-25
00840416607130FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607147FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607154FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607161FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607178FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607185FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
08720938410383Cardiac, 10-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410390Cardiac, 10-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410406IR, 5-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410413IR, 5-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410420ACIST FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410437Volcano (Philips) FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410444ABBOTT FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410451BOSTON FFR Connection KitFysicon B.V.DSA2026-08-14
00840416607079FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607086FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607093FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607109FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607116FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607123FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840309445672Viva ComfortTiger Supplies IncDSA2026-08-01
00840309445689Viva ComfortTiger Supplies IncDSA2026-08-01
G662ME3641MaguireMaguire Enterprises, Inc.DSA2026-07-31
G662ME5900951MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590333B1MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590280L1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280M1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280T11MaguireMaguire Enterprises, Inc.DSA2026-07-28