DEVICE: Oral Tamper Evident Cap (B212172861)

Device Identifier (DI) Information

Oral Tamper Evident Cap
17286
In Commercial Distribution
17286
INTERNATIONAL MEDICAL INDUSTRIES INC.
B212172861
HIBCC

100
053469565 *Terms of Use
Oral Tamper Evident Cap for Baxter / ExactaMed Oral Dispenser. Non-Sterile, Bag of 100, Box of 1000. Provides Evidence of Access and Positive Closure
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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
Oral liquid dose dispenser A device designed to distribute oral liquid medication/vitamins in a healthcare facility in the amount needed for a single dose for an individual patient. It typically consists of a small cabinet (e.g., wall-mounted, tabletop, or self-standing) that contains unit-dose packaged liquid drugs (e.g., glass ampules, sealed plastic containers) and/or containers with multiple doses but that only dispense an exact amount of liquid at a time, preventing the operator access to the remaining stock of drugs.
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FDA Product Code

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Product Code Product Code Name
KYX Dispenser, Liquid Medication
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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
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

2350823a-0c03-4f7c-9ca7-4a58c1dbf9f4
March 29, 2018
2
October 14, 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
B212172862 10 B212172861 In Commercial Distribution 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: B212172860 CLOSE

Direct Marking (DM)

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

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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