DLW,4 LEAD,PINCH,CARESCAPE,40",AHA 29118

GUDID 00840828193184

CURBELL MEDICAL PRODUCTS, INC.

Electrocardiographic electrode, single-use
Primary Device ID00840828193184
NIH Device Record Key7060b06b-a738-4b3b-b10e-abfa5ababff5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDLW,4 LEAD,PINCH,CARESCAPE,40",AHA
Version Model NumberDLW-04BG-40AS-0000
Catalog Number29118
Company DUNS796452311
Company NameCURBELL MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com
Phone1-800-235-7500
Emailmwinter@curbellmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840828193184 [Package]
Contains: 00840828193214
Package: Case [2 Units]
In Commercial Distribution
GS100840828193191 [Package]
Contains: 00840828193214
Package: Case [10 Units]
In Commercial Distribution
GS100840828193214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSACable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-15
Device Publish Date2024-10-07

Devices Manufactured by CURBELL MEDICAL PRODUCTS, INC.

00840828194310 - GEN4 PLUS, DIRECT ACCESS2025-04-25
00840828194327 - GEN4 PLUS, DIRECT ACCESS2025-04-25
00840828194334 - GEN4 INTERACTIVE2025-04-25
00840828194341 - GEN4 PLUS, DIRECT ACCESS2025-04-25
00840828194358 - GEN4 INTERACTIVE2025-04-25
00840828194365 - RESPONDER 5, INTERACTIVE2025-04-25
00840828194372 - RESPONDER 5, INTERACTIVE2025-04-25
00840828194389 - RESPONDER 5, INTERACTIVE2025-04-25

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