FDA.reportPublic FDA data

SPO2 AD CB,NK 14M,DB9F KEY,2M

Primary DI
00840828189859
Brand
SPO2 AD CB,NK 14M,DB9F KEY,2M
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
OCT111
Catalog number
28573
Device description
SPO2 AD CB,NK 14M,DB9F KEY,2M
Published
2023-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)
ILQSystem, Communication, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
ILQSystem, Communication, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222370000SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd.2023-04-02DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840828189859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828189859008408281898598408281898590840828189859

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. 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
008408281968570103,SCC,10',RAULAND LABELED,UL,PVC-FREE370260308932026-07-23
00840828196864GEN4 DIRECT ACCESS4C331U-Z10501H308832026-07-23
00840828196871GEN4 INTERACTIVE415400N-0500018308842026-07-23
00840828196888US MATT PAD-UNI-CONNECT-18MO-10X15CSP-US-U10308902026-07-23
00840828196895PAD-CORDED,UNDER SEAT,10"X15",92" CORDCSP-US-C10-92308912026-07-23
00840828196901PAD WIRELESS, UNDER SEAT, 10"X15"CSP-US-W10308922026-07-23
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840416607093FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607109FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607116FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607123FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840309445672Viva ComfortTiger Supplies IncDSA2026-08-01
00840309445689Viva ComfortTiger Supplies IncDSA2026-08-01
G662ME3641MaguireMaguire Enterprises, Inc.DSA2026-07-31
G662ME5900951MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590333B1MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590280L1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280M1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280T11MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280Y1MaguireMaguire Enterprises, Inc.DSA2026-07-28
03700506300853INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-07-24
00840828196895PAD-CORDED,UNDER SEAT,10"X15",92" CORDCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-23
00840828196901PAD WIRELESS, UNDER SEAT, 10"X15"CURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-23
G662ME5900321MaguireMaguire Enterprises, Inc.DSA2026-07-23
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00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022577ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022706ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022713ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08