FDA.reportPublic FDA data

DLA,5 LEAD,SNAP,MULTILINK,MOLDED,40",AHA

Primary DI
90840828179983
Brand
DLA,5 LEAD,SNAP,MULTILINK,MOLDED,40",AHA
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
DLA-05AD-40AM-0000
Catalog number
24570
Device description
DLA,5 LEAD,SNAP,MULTILINK,MOLDED,40",AHA
Published
2020-04-22
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90840828179983PackageGS12In Commercial Distribution
90840828179990PackageGS110In Commercial Distribution
90840828174797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9084082817998390840828179983
9084082817999090840828179990
9084082817479790840828174797

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
false
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
00840828196178JUMPER,6",S102 TO 7 PIN DINJU06-626306542026-03-20
00840828187374SURE LOCK, ASSEMBLY, A34, BLUE LEVERSLC-4200-006277592023-01-09
00840828196109GEN4 PLUS, DIRECT ACCESS5C383U-Z10300008306042026-03-11
00840828196116GEN4 INTERACTIVE4G331E-0148798305822026-03-11
00840828196123RESPONDER 5, INTERACTIVE5I4112U-B64453A306142026-03-11
00840828196130RESPONDER 5, INTERACTIVE5I4112U-101471A306052026-03-11
00840828196147RESPONDER 5, INTERACTIVE5I4112U-500001A306082026-03-11
00840828196154RESPONDER 5, INTERACTIVE5I411U-F00001A306112026-03-11
00840828196161GEN4 INTERACTIVE414430U-0151049306152026-03-11
00840828196079GEN4 DIRECT ACCESS4C19NN-Z10200A305452026-03-04
00840828196086GEN4 DIRECT ACCESS4C19NN-Z10200C305462026-03-04
00840828196093RESPONDER 5, INTERACTIVE5I4112U-001462A306012026-03-04
00840828196000GEN4 INTERACTIVE43319FU-0143088305712026-03-03
00840828196017GEN4 INTERACTIVE4X331E-000503C305812026-03-03
00840828196024RESPONDER 5, INTERACTIVE5I41JU-363465A305862026-03-03
00840828196031GEN4 INTERACTIVE414370E-010346A305932026-03-03
00840828196048RESPONDER 5, INTERACTIVE5I41JU-363425A305942026-03-03
00840828196055GEN4 INTERACTIVE4M370E-Z749368305962026-03-03
00840828196062GEN4 INTERACTIVE4M370E-Z749448305982026-03-03
00840828195966ZEPHYR,800,10,PUFF,JERON 680GEB-19C0-203A-N305512026-02-11

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