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
00840828196710P4600 90°,S4600,1 FT,R6,PS BREAKAWAYJUP-4600-1308492026-07-08
008408281967274600,R6,BASIC,2 LT,DV370202308542026-07-08
008408281967344600,R6,ENH,2 LT,DV370250308562026-07-08
00840828196741RESPONDER 5, INTERACTIVE4D41BN-A64403A308682026-07-08
00840828196758GEN4 INTERACTIVE4U190E-010402A308202026-07-08
00840828196765RESPONDER 5, INTERACTIVE5I41PU-100001A308232026-07-08
00840828196772RESPONDER 5, INTERACTIVE5I41PU-100041A308262026-07-08
00840828196789GEN4 INTERACTIVE437370U-0103448308712026-07-08
00840828196796GEN4 INTERACTIVE437370U-0100448308722026-07-08
00840828196802GEN4 INTERACTIVE43719FU-0104008308732026-07-08
00840828196819GEN4 INTERACTIVE43719FU-0103008308742026-07-08
00840828196826GEN4 INTERACTIVE433430U-0103009308772026-07-08
00840828196833GEN4 INTERACTIVE4X330E-010301C308782026-07-08
00840828196840GEN4 DIGITAL4D190U-0250028308662026-07-08
00840828196666GEN4 INTERACTIVE414331E-9143018308052026-06-09
00840828196673GEN4 INTERACTIVE438400N-0500018308032026-06-09
00840828196680RESPONDER 5, INTERACTIVE5I411U-165031A308082026-06-09
00840828196468RESPONDER 5, INTERACTIVE5I4112U-101463A307532026-05-27
00840828196475GEN4 INTERACTIVE412331U-0103018307602026-05-27
00840828196482GEN4 INTERACTIVE412331U-0105018307612026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
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00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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