FDA.reportPublic FDA data

NA

Primary DI
20653405036262
Brand
NA
Company
Conmed Corporation
Model
38-630-S
Catalog number
38-630-S
Device description
DISPERSIVE ELECTRODE ADAPTERS
Published
2021-02-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, electrocardiograph
IKDCABLE, ELECTRODE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2
IKDCable, ElectrodePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K761301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K761301000V-TRACE ECG BACKPADNdm Corp.1977-01-05DRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405036262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2065340503626220653405036262

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead switching adaptorA switching device to which electrocardiograph (ECG) limb and chest leads may be attached. It is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations (e.g., leads I, II and III). This device will typically be used when the devices to be connected are from different manufacturer's, enabling them to mate together. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length33Millimeter
Width5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-29 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-20 Degrees Fahrenheit140 Degrees Fahrenheit
Special Storage Condition, Specify0016 - 27 Degrees Celsius
Special Storage Condition, Specify0030 - 75 Relative Humidity
Special Storage Condition, Specify0060 - 80 Degrees Fahrenheit
Storage Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 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
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10845854031841CONMEDT2531T25312020-12-10
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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
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20653405051920Precisor0008540008542016-09-24
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30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03664539003610NADIXI MEDICALIKD2022-07-06
03664539003627NADIXI MEDICALIKD2022-07-06
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