DEVICE: MediChoice (10885632066009)

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Device Record History
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Device Identifier (DI) Information
MediChoice
DCL10005
In Commercial Distribution

OWENS & MINOR DISTRIBUTION, INC.
10885632066009
GS1

1
007941230 *Terms of Use
Leadset Disposable 5 Lead, GE Direct Connect 0.9M Snap
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Device Characteristics
MR Unsafe
No
Yes
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61821 Electrocardiographic lead set, single-use
A 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 to assist electrode placement. This is a single-use device.
Active false
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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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify:
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Special Storage Condition, Specify: Aovid Freezing and Excessive Heat
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
fe7ae889-a079-41d9-b042-8c9502a66a1a
June 06, 2024
3
August 03, 2017
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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
30885632066003 20 20885632066006 In Commercial Distribution
20885632066006 10 10885632066009 In Commercial Distribution
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Secondary DI

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

[?]
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
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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