FDA.reportPublic FDA data

Nellcor

Primary DI
20884521705347
Brand
Nellcor
Company
Covidien LP
Model
PMC10GE360N
Device description
GE CARESCAPE SpO2 - Nellcor. For use with GE Patient Monitors.
Published
2018-03-22
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
K172482000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172482000The Nellcor pulse oximetry monitor interface cableCovidien2017-12-15DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521705347PackageGS120In Commercial Distribution
10884521705340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452170534720884521705347
1088452170534010884521705340

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.6Meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Atmospheric Pressure50 KiloPascal108 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

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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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572900APKAPK Technology Co.,Ltd.DQA2026-10-26
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06946725516935APKAPK Technology Co.,Ltd.DQA2026-03-12
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06946725516966APKAPK Technology Co.,Ltd.DQA2026-03-12
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06946725517024APKAPK Technology Co.,Ltd.DQA2026-03-12
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06946725517086APKAPK Technology Co.,Ltd.DQA2026-03-12