FDA.reportPublic FDA data

DLA,6 LEAD,SNAP,MULTILINK,MOLDED,40",AHA

Primary DI
90840828180088
Brand
DLA,6 LEAD,SNAP,MULTILINK,MOLDED,40",AHA
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
DLA-06AD-40AM-0000
Catalog number
26059
Device description
DLA,6 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
90840828180088PackageGS12In Commercial Distribution
90840828180095PackageGS110In Commercial Distribution
90840828180071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9084082818008890840828180088
9084082818009590840828180095
9084082818007190840828180071

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
00840828197007GEN4 INTERACTIVE4X331E-0D50508309072026-08-18
00840828197014RESPONDER 5, INTERACTIVE5I4116U-101453A309302026-08-18
008408281968570103,SCC,10',RAULAND LABELED,UL,PVC-FREE370260308932026-07-23
00840828196864GEN4 DIRECT ACCESS4C331U-Z10501H308832026-07-23
00840828196871GEN4 INTERACTIVE415400N-0500018308842026-07-23
00840828196888US MATT PAD-UNI-CONNECT-18MO-10X15CSP-US-U10308902026-07-23
00840828196895PAD-CORDED,UNDER SEAT,10"X15",92" CORDCSP-US-C10-92308912026-07-23
00840828196901PAD WIRELESS, UNDER SEAT, 10"X15"CSP-US-W10308922026-07-23
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

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