FDA.reportPublic FDA data

DISP NLCR COMPAT SPO2 SNSR, OXMX,MAXP

Primary DI
00840828184243
Brand
DISP NLCR COMPAT SPO2 SNSR, OXMX,MAXP
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
CSA001DP-P300
Catalog number
27086
Device description
DISP NLCR COMPAT SPO2 SNSR, OXMX,MAXP
Published
2021-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
00840828189552PackageGS124In Commercial Distribution
10840828184240PackageGS130In Commercial Distribution
00840828184243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828189552008408281895528408281895520840828189552
1084082818424010840828184240
00840828184243008408281842438408281842430840828184243

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, single-useA 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. The is a single-use device.

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840828196468RESPONDER 5, INTERACTIVE5I4112U-101463A307532026-05-27
00840828196475GEN4 INTERACTIVE412331U-0103018307602026-05-27
00840828196482GEN4 INTERACTIVE412331U-0105018307612026-05-27
00840828196499GEN4 INTERACTIVE412331U-0147018307622026-05-27
00840828196505GEN4 INTERACTIVE412331U-0147178307632026-05-27
00840828196512GEN4 INTERACTIVE412331U-0143018307642026-05-27
00840828196529GEN4 INTERACTIVE412331U-0147171307652026-05-27
00840828196536GEN4 INTERACTIVE412331U-0150018307662026-05-27
00840828196543GEN4 INTERACTIVE412331U-0145518307672026-05-27
00840828196550GEN4 INTERACTIVE412331U-0100008307682026-05-27
00840828196567GEN4 INTERACTIVE412331U-0100018307692026-05-27
00840828196574GEN4 INTERACTIVE412331U-0119018307702026-05-27
00840828196581GEN4 INTERACTIVE412331U-014701C307712026-05-27
00840828196598GEN4 INTERACTIVE412331U-0105011307722026-05-27
00840828196604GEN4 INTERACTIVE412331U-0153518307732026-05-27
00840828196611GEN4 INTERACTIVE412331U-015400C307742026-05-27
00840828196628GEN4 INTERACTIVE412331U-0155588307752026-05-27
00840828196635GEN4 INTERACTIVE412331U-0156518307762026-05-27
00840828196642GEN4 INTERACTIVE412331U-014717C307772026-05-27
00840828196659GEN4 INTERACTIVE412331U-014301C307782026-05-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06920485308450BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DQA2026-06-01
10884521855397NellcorCovidien LPDQA2026-05-29
10884521855403NellcorCovidien LPDQA2026-05-29
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B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
09551028900069Cables and SensorsXINMED SDN. BHD.DQA2026-04-22
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08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03