FDA.reportPublic FDA data

Nellcor

Primary DI
10884521855403
Brand
Nellcor
Company
Covidien LP
Model
PMC10GE360N
Device description
Nellcor (TM) SpO2 MM;For use with GE HealthCare devices.
Published
2026-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
10884521855403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452185540310884521855403

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
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00Keep dry
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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10884521099289Chemosite1200892015-09-28
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10884521783829LigaSureMRASILF192026-10-23
10884521853812Shiley1108602026-10-25
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10884521853836Shiley1108702026-10-25
10884521853843Shiley1108752026-10-25
10884521853850Shiley1108802026-10-25
10884521853867Shiley1108852026-10-25
10884521853874Shiley1108902026-10-25
10884521856547Touch SurgeryMDS300282026-10-23
10884521861114Vital SyncVITALSYNCSW032026-10-25
10884521039902Surgipro llVPF-703-MX2015-09-02
10884521063433Ti-CronX-11362015-09-02
10884521073951Versaport PlusNB8STF2016-09-24
10884521195677Surgipro IIVP-653-MX2015-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572900APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725572948APKAPK Technology Co.,Ltd.DQA2026-10-26
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06946725516829APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516836APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516843APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516850APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516867APKAPK Technology Co.,Ltd.DQA2026-03-12
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06946725516881APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516898APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516904APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516911APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516928APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516935APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516942APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516959APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516966APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516973APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516980APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725516997APKAPK Technology Co.,Ltd.DQA2026-03-12
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06946725517024APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517031APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517048APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517055APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517062APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517079APKAPK Technology Co.,Ltd.DQA2026-03-12
06946725517086APKAPK Technology Co.,Ltd.DQA2026-03-12