FDA.reportPublic FDA data

"DISP NONN COMP SPO2 SNSR,6000CP,PDTR,39"""

Primary DI
00840828190503
Brand
"DISP NONN COMP SPO2 SNSR,6000CP,PDTR,39"""
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
CSA020DP-P200
Catalog number
28801
Device description
DISP NONIN COMP SPO2 SNSR,6000CP,PDTRC,39”,CLR FLM,NON-STRL,EA
Published
2023-11-07
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
10840828190500PackageGS124In Commercial Distribution
00840828190503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084082819050010840828190500
00840828190503008408281905038408281905030840828190503

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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10884521855397NellcorCovidien LPDQA2026-05-29
10884521855403NellcorCovidien LPDQA2026-05-29
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