FDA.reportPublic FDA data

CONMED

Primary DI
00653405027587
Brand
CONMED
Company
Conmed Corporation
Model
RLB-10
Catalog number
RLB-10
Device description
ECG Leadwires
Published
2023-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCABLE, ELECTRODE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912415000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912415000MEDICAL SAFETY CABLE AND LEAD SYSTEMMedtronic Vascular1991-08-16BZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30653405027588PreviousGS10
20653405027581PrimaryGS10
00653405027587Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3065340502758830653405027588
2065340502758120653405027581
00653405027587006534050275876534050275870653405027587

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Handling Environment Temperature41 Degrees Fahrenheit95 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
10
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
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31
20653405990939GENESYS™ CrossFT™CFBC-5503RCFBC-5503R2026-07-31
20653405990946GENESYS™ CrossFT™CFBC-6502RCFBC-6502R2026-07-31
20653405990953GENESYS™ CrossFT™CFBC-6503RCFBC-6503R2026-07-31
10653405000242YANKAUER003447000344702016-09-24
10845854035559E9000E9015E90152026-03-24
20653405008559CONMED60-0824-00160-0824-0012016-09-24
30653405003230CONMED1380111380112016-09-24
30653405003247CONMED1380121380122016-09-24
30653405058230AER DEFENSE60-8084-00160-8084-0012016-09-24
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860004773733AtriAmp - Pacing CableAtrility Medical LLCIKD2026-08-18
06946725571736APKAPK Technology Co.,Ltd.IKD2026-08-15
06946725512173APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725513521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725555262APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568439APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568446APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568453APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568460APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568477APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568484APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568491APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568507APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568514APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568538APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568545APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568552APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568569APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568576APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568705APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568859APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569429APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569436APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569467APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569474APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570005APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570142APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725571040APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725571989APKAPK Technology Co.,Ltd.IKD2026-08-14