FDA.reportPublic FDA data

SURE LOCK, ASSEMBLY, A34, BLUE LEVER

Primary DI
00840828187374
Brand
SURE LOCK, ASSEMBLY, A34, BLUE LEVER
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
SLC-4200-006
Catalog number
27759
Device description
SURE LOCK, ASSEMBLY, A34, BLUE LEVER
Published
2023-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K080605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080605000SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TLCurbell Electronics, Inc.2008-05-05DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840828187459PackageGS114In Commercial Distribution
00840828188975PackageGS110In Commercial Distribution
00840828187374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828187459008408281874598408281874590840828187459
00840828188975008408281889758408281889750840828188975
00840828187374008408281873748408281873740840828187374

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode connectorA small clip designed to enable an electrical connection between an electrocardiographic electrode and an electrocardiographic lead wire. It is typically made of plastic materials, with a metallic part to provide electrical connection, and can be manually applied to a dedicated area of a disk-like electrode that is placed on the patient’s skin, with a socket at the other end for a plug on the lead. 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
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840416606898FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606904FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606911FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606928FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606935FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606942FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606959FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
08719689142209QMAPP Fysicon B.V.DSA2026-05-19
08719689142216QMAPP Fysicon B.V.DSA2026-05-19
08719689142223QMAPP Fysicon B.V.DSA2026-05-19
08719689142247QMAPP Fysicon B.V.DSA2026-05-19
08719689142254QMAPP Fysicon B.V.DSA2026-05-19
08719689142261QMAPP Fysicon B.V.DSA2026-05-19
08719689142322QMAPPFysicon B.V.DSA2026-05-19
08719689142339QMAPPFysicon B.V.DSA2026-05-19
08719689142346QMAPPFysicon B.V.DSA2026-05-19
08719689142353QMAPPFysicon B.V.DSA2026-05-19
08719689142360QMAPPFysicon B.V.DSA2026-05-19
08719689142377QMAPPFysicon B.V.DSA2026-05-19
08719689142384QMAPPFysicon B.V.DSA2026-05-19
08719689142391QMAPPFysicon B.V.DSA2026-05-19
08719689142407QMAPPFysicon B.V.DSA2026-05-19
08719689142414QMAPPFysicon B.V.DSA2026-05-19
08719689142469QMAPPFysicon B.V.DSA2026-05-19
08719689142476QMAPPFysicon B.V.DSA2026-05-19
08719689142483QMAPPFysicon B.V.DSA2026-05-19
08719689142490QMAPPFysicon B.V.DSA2026-05-19
08719689142506QMAPPFysicon B.V.DSA2026-05-19
08719689142513QMAPPFysicon B.V.DSA2026-05-19
08719689142520QMAPPFysicon B.V.DSA2026-05-19