FDA.reportPublic FDA data

DLW,4 LEAD,SNAP,CARESCAPE,40",AHA

Primary DI
00840828193160
Brand
DLW,4 LEAD,SNAP,CARESCAPE,40",AHA
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
DLW-04AG-40AS-0000
Catalog number
29117
Published
2024-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
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
K081762000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081762000CURBELL PATIENT MONITORING CABLESCurbell Electronics, Inc.2008-08-27DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840828193160PackageGS12In Commercial Distribution
00840828193177PackageGS110In Commercial Distribution
00840828193207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828193160008408281931608408281931600840828193160
00840828193177008408281931778408281931770840828193177
00840828193207008408281932078408281932070840828193207

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, 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, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-235-7500mwinter@curbellmedical.com

Regulatory Flags#

DUNS number
796452311
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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00840416607406FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
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00840416607420FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
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G662ME590221F1MaguireMaguire Enterprises, Inc.DSA2026-10-19
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G662ME3311MaguireMaguire Enterprises, Inc.DSA2026-10-09
G662ME3381MaguireMaguire Enterprises, Inc.DSA2026-10-09
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00840416607352FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
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00840416607376FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
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00840416607390FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
G662ME590015H1MaguireMaguire Enterprises, Inc.DSA2026-09-24
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-09-20
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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