DEVICE: Unimed (06945664836029)

Device Identifier (DI) Information

Unimed
L02V-05-DS
In Commercial Distribution

Unimed Medical Supplies, Inc.
06945664836029
GS1

1
527971025 *Terms of Use
Disposable ECG Lead Wires/MV type/5-lead(Chest)/Snap/AHA/0.9M/Sage Services GROUP
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electrocardiographic lead set, single-use A collection of non-sterile, 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 to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DSA Cable, Transducer And Electrode, Patient, (Including Connector)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K142489 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

384ccdb3-4a6f-4998-86a8-f7dc5ed815df
July 06, 2018
3
August 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
16945664836026 10 06945664836029 In Commercial Distribution carton box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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