FDA.report

Unimed

Primary DI
06936735463534
Brand
Unimed
Company
Unimed Medical Supplies, Inc.
Model
GE-412682-001
Device description
ECG Monitor Lead Wire GE Marquette Style 3-lead shielded grabber end 0.9m/AHA
Published
2022-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06936735463534PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
527971025
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
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 DIBrandModelCatalogPublished
06936735488353UnimedD6-RT180D-I2025-09-26
06936735497195Unimed D33-16161-I2025-09-26
06936735496501UnimedD33-13161-I2025-03-28
06936735494200Unimed24155P2025-03-13
06936735494675Unimed24155P-I2025-03-13
06936735495214UnimedE10R/30-KAR-P2025-03-13
06936735496099UnimedE10R/30-KAR-P/I2025-03-13
06936735496570UnimedAD-KAR-2101482025-03-13
06936735450503UnimedU410B-372022-04-11
06936735450510Unimed U410E-1212022-04-11
06936735450527UnimedU110-65D2022-04-11
06936735450534UnimedPU410S-01P2022-04-11
06936735450541UnimedU410-2242022-04-11
06936735451463UnimedU4M10-08L(NPS)2022-05-27
06936735451470UnimedT533-49R2022-05-27
06936735451487UnimedU310-195P2022-05-27
06936735451500UnimedU103S-2542022-05-27
06936735454105Unimed GS DP-11/A2022-11-01
06936735454518Unimed PU110-46D2022-12-08
06936735454525Unimed PU903-2032022-12-09

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