DEVICE: DANLEE MEDICAL KIT (00081631002170)

Device Identifier (DI) Information

DANLEE MEDICAL KIT
D0B1R5AB
In Commercial Distribution

DANLEE MEDICAL PRODUCTS, INC
00081631002170
GS1

1
878130871 *Terms of Use
ECG PREP KIT (ZKIT) CONMED- KIT DI NUMBER ERROR DURING ENTRY (CORRECTION RE-ENTERED SEE 00816310021709)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
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 long-term ambulatory recording support kit A collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 5 and 35 Degrees Celsius
Storage Environment Temperature: between 41 and 95 Degrees Fahrenheit
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

06cbf276-0ece-491c-aa6a-86a8b568207f
March 29, 2018
2
November 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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

[?]
No
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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