FDA.report

Unimed

Primary DI
06936735468614
Brand
Unimed
Company
Unimed Medical Supplies, Inc.
Model
CB-5L1666A
Device description
ECG Monitor Trunk Cable Fukuda
Published
2023-03-24
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
06936735468614PrimaryGS10

GMDN Terms

TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. 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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