EMMA™ Kit

Primary DI
07350046131040
Brand
EMMA™ Kit
Company
MASIMO CORPORATION
Model
3678
Catalog number
3678
Device description
EMMA™ Kit
Published
2016-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063167000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063167000EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)Phasein AB2007-02-06CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350046131040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350046131040073500461310407350046131040

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, carbon dioxideA small unit dedicated to the measurement of carbon dioxide (CO2) content of expired gas obtained through a sampling tube connected to a main respiratory channel (mainstream) or a side-channel (sidestream) of a breathing circuit. It is designed to operate as part of a patient monitoring system enhancing the function of this (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or in a connected module rack. The parent device operates as a mainframe computer displaying the CO2 parameter/information measured and provided by this module.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
780421038
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00843997016018Radius VSM46952026-02-23
00843997015530Rad-G YI Multisite Reusable Sensor46532021-10-08
10843997003381LNCS26902024-08-16
10843997003398LNCS26912024-08-16
10843997003404LNCS26922024-08-16
10843997003411LNCS26942024-08-16
10843997004968MasimoSET LNCS® E1™ SpO2 Adult Pulse Oximeter Adhesive Sensor291829182016-08-24
10843997010921RD rainbow SET-240282020-09-03
10843997010938RD rainbow SET-240292020-09-03
10843997013496O343842020-09-03
00843997010825rainbow SET418341832023-02-13
00843997010818rainbow SET41822022-11-21
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10843997002803MasimoSET® LNCS® Pdtx-3 SpO2 Pediatric Pulse Oximeter Adhesive Sensor260226022016-08-24
10843997002810MasimoSET® LNCS® Inf-3 SpO2 Infant Pulse Oximeter Adhesive Sensor260326032016-08-24