FDA.reportPublic FDA data

"SPO2 AD CB,PHILIPS/HP 8M,DB9F,8"""

Primary DI
00840828193429
Brand
"SPO2 AD CB,PHILIPS/HP 8M,DB9F,8"""
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
OCT018-SS
Catalog number
29439
Published
2024-11-08
Public version status
New
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)

Product Code Classifications#

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

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
00840828193429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828193429008408281934298408281934290840828193429

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04048675746768Temp adapter Jack Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.DSA2026-07-13
06931973403939CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
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