FDA.reportPublic FDA data

Nellcor

Primary DI
20884521139623
Brand
Nellcor
Company
Covidien LP
Model
10076645
Device description
SpO2 Module,For use with Philips IntelliVue Patient Monitors.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060576000NELLCOR OXIMAX N-600X PULSE OXIMETERNellcor Puritan Bennett, Inc.2006-08-14DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521139623PackageGS125In Commercial Distribution
10884521139626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452113962320884521139623
1088452113962610884521139626

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, pulse oximetryA small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (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 a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure57 KiloPascal101 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature32 Degrees Fahrenheit113 Degrees Fahrenheit
Special Storage Condition, Specify00Keep Dry
Storage Environment Atmospheric Pressure11 KiloPascal107 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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10884521861114Vital SyncVITALSYNCSW032026-10-25
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10884521702073Surgipro IIVP746XG2017-10-10
10884521702172SurgiproCP41G2017-10-10
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06946725516317APKAPK Technology Co.,Ltd.DQA2026-03-11
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06946725516331APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516348APKAPK Technology Co.,Ltd.DQA2026-03-11
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06946725516409APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516416APKAPK Technology Co.,Ltd.DQA2026-03-11
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06946725516454APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516461APKAPK Technology Co.,Ltd.DQA2026-03-11