FDA.reportPublic FDA data

SURE LOCK,A34,10 PK,BLUE,PHILIPS/CURBELL

Primary DI
00840828183505
Brand
SURE LOCK,A34,10 PK,BLUE,PHILIPS/CURBELL
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
CL-10402-06-10
Catalog number
26871
Device description
SURE LOCK,A34,10 PK,BLUE,PHILIPS/CURBELL
Published
2021-05-14
Public version status
New
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
00840828183505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828183505008408281835058408281835050840828183505

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, reusableA noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, or adhesive tape, and a conductive gel (some are pre-gelled), or using a suction mechanism; alternatively, some types may be designed to be attached to hand-held heart rate meters. Electrocardiography (ECG) is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. 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
00840828197021GEN4 INTERACTIVE418430U-0104029309322026-10-15
00840828197038GEN4 INTERACTIVE418430U-0637009309332026-10-15
00840828197052GEN4 INTERACTIVE433383U-0134008309482026-10-15
00840828197069US MATT PAD-UNI-CONNECT-NO LOGOCSP-US-U10-NL309552026-10-15
00840828197076RESPONDER 5, INTERACTIVE5I4125U-162443A309702026-10-15
00840828197083RESPONDER 5, INTERACTIVE5I4128U-101023A309622026-10-15
00840828197090GEN4 INTERACTIVE439331U-0142018309652026-10-15
00840828197106GEN4 DIRECT ACCESSDARPSV-5007309432026-10-15
00840828197113GEN4 INTERACTIVE42521VU-0736018309522026-10-15
00840828197137GEN4 INTERACTIVE4G19TU-0131008310012026-10-15
00840828197144MBA-BE,S37,INL,1'BCC-5801-A01307882026-10-15
00840828197151MBA-BE,S37,INL,6'BCC-5801-A06307892026-10-15
00840828197168MBA-BE,P37,INL,1'BCC-5801-E01307902026-10-15
00840828197175MBA-BE,P37,INL,6'BCC-5801-E06307912026-10-15
00840828197182MBA-WE,P37,INL,1',DPBCC-5802-A01-001307922026-10-15
00840828197199MBA-WE,P37,INL,6',DPBCC-5802-A06-001307932026-10-15
00840828197205MBA-WE,P37(90),1',DPBCC-5803-A01-001307942026-10-15
00840828197212MBA-WE,P37(90),6',DPBCC-5803-A06-001307952026-10-15
00840828197229GEN4 INTERACTIVE4M190E-Z700038310062026-10-15
00840828197236GEN4 INTERACTIVE439430U-0143009310452026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHDSA2026-10-21
G662ME361G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
G662ME368G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
00840416607406FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607413FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607420FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607437FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607444FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
G662ME590221F1MaguireMaguire Enterprises, Inc.DSA2026-10-19
G662ME590303G1MaguireMaguire Enterprises, Inc.DSA2026-10-16
00195278840202MACGe Medical Systems Information Technologies, Inc.DSA2026-10-13
06946725572139APKAPK Technology Co.,Ltd.DSA2026-10-13
042504134004853-channel ECG ElectrodeSOMNOmedics AGDSA2026-10-09
G662ME3311MaguireMaguire Enterprises, Inc.DSA2026-10-09
G662ME3381MaguireMaguire Enterprises, Inc.DSA2026-10-09
00840416607345FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607352FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607369FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607376FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607383FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607390FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
G662ME590015H1MaguireMaguire Enterprises, Inc.DSA2026-09-24
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-09-20
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
G662ME590032R1MaguireMaguire Enterprises, Inc.DSA2026-08-25
00840416607130FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607147FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607154FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607161FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607178FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17