FDA.reportPublic FDA data

CONMED

Primary DI
20653405027246
Brand
CONMED
Company
Conmed Corporation
Model
RL24-03II
Catalog number
RL24-03II
Device description
"ECG LEADWIRES, SAFETY, GRABBER, 24"", BLACK, RED, WHITE"
Published
2023-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZQMonitor, breathing frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2

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
30653405027243PreviousGS10
20653405027246PrimaryGS10
00653405027242Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3065340502724330653405027243
2065340502724620653405027246
00653405027242006534050272426534050272420653405027242

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or 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
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit95 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
3
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyBZQ2026-04-15
20653405024962CONMEDConmed CorporationBZQ2026-03-24
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10889483225295MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
00850064210309ANNE Chest Adhesive - Gentle Wear Shelf BoxSibel Health Inc.BZQ2025-12-17
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.BZQ2025-12-10
07640121881053103583 LuMon™ Contact Gel KitSenTec AGBZQ2025-09-08
10889483610565Resmed Sleep Apnealink CannulaSALTER LABSBZQ2025-07-11
00850064210200Sibel Spacelabs Trek Chest PatchSibel Health Inc.BZQ2025-04-02
00850064210224Sibel Spacelabs Trek ChargerSibel Health Inc.BZQ2025-04-02
00850064210248Sibel Spacelabs Trek Chest Patch AdhesiveSibel Health Inc.BZQ2025-04-02
00850068747092Happy HealthHAPPY HEALTH, INC.BZQ2025-04-02
00850068747108Happy HealthHAPPY HEALTH, INC.BZQ2025-04-02
00850068747115Happy HealthHAPPY HEALTH, INC.BZQ2025-04-02
00850064210002ANNE Chest Sensor KitSibel Health Inc.BZQ2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.BZQ2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.BZQ2025-03-26
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.BZQ2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.BZQ2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.BZQ2025-03-26
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.BZQ2025-03-13
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDBZQ2025-03-05
G2331000000SansaTMHuxley Medical, Inc.BZQ2024-10-21
G2331000010SansaTMHuxley Medical, Inc.BZQ2024-10-21
G2331000020SansaTMHuxley Medical, Inc.BZQ2024-10-21
10843997006184Radius VSMMASIMO CORPORATIONBZQ2024-08-19
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZQ2024-06-19
00195278656681Portrait CVAXBGE Medical Systems Information Technologies, Inc.BZQ2024-04-30
00195278659446Portrait CSSXBGE Medical Systems Information Technologies, Inc.BZQ2024-04-30
00195278697165PORTRAIT HSWXBGE Healthcare Finland OyBZQ2024-04-30