FDA.reportPublic FDA data

REUS,PHILIPS SPO2 SNSR,9.5',LG CLAM

Primary DI
00840828194686
Brand
REUS,PHILIPS SPO2 SNSR,9.5',LG CLAM
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
CSJ017CA
Catalog number
30156
Device description
REUS,PHILIPS SPO2 SNSR,9.5',LG CLAM
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103685000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103685000PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CABeijing Rongrui-Century Scie. & Tech. Co., Ltd.2011-07-15DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840828194686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828194686008408281946868408281946860840828194686

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-235-7500mwinter@curbell.com

Regulatory Flags#

DUNS number
796452311
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840828197021GEN4 INTERACTIVE418430U-0104029309322026-10-15
00840828197038GEN4 INTERACTIVE418430U-0637009309332026-10-15
00840828197052GEN4 INTERACTIVE433383U-0134008309482026-10-15
00840828197069US MATT PAD-UNI-CONNECT-NO LOGOCSP-US-U10-NL309552026-10-15
00840828197076RESPONDER 5, INTERACTIVE5I4125U-162443A309702026-10-15
00840828197083RESPONDER 5, INTERACTIVE5I4128U-101023A309622026-10-15
00840828197090GEN4 INTERACTIVE439331U-0142018309652026-10-15
00840828197106GEN4 DIRECT ACCESSDARPSV-5007309432026-10-15
00840828197113GEN4 INTERACTIVE42521VU-0736018309522026-10-15
00840828197137GEN4 INTERACTIVE4G19TU-0131008310012026-10-15
00840828197144MBA-BE,S37,INL,1'BCC-5801-A01307882026-10-15
00840828197151MBA-BE,S37,INL,6'BCC-5801-A06307892026-10-15
00840828197168MBA-BE,P37,INL,1'BCC-5801-E01307902026-10-15
00840828197175MBA-BE,P37,INL,6'BCC-5801-E06307912026-10-15
00840828197182MBA-WE,P37,INL,1',DPBCC-5802-A01-001307922026-10-15
00840828197199MBA-WE,P37,INL,6',DPBCC-5802-A06-001307932026-10-15
00840828197205MBA-WE,P37(90),1',DPBCC-5803-A01-001307942026-10-15
00840828197212MBA-WE,P37(90),6',DPBCC-5803-A06-001307952026-10-15
00840828197229GEN4 INTERACTIVE4M190E-Z700038310062026-10-15
00840828197236GEN4 INTERACTIVE439430U-0143009310452026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
07290019919346OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919414OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919421OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919438OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQA2026-10-04
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06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
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06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
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