DEVICE: Oral Tamper Evident Cap (B21257751)

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Device Record History
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Device Identifier (DI) Information
Oral Tamper Evident Cap
57-75
In Commercial Distribution
57-75
INTERNATIONAL MEDICAL INDUSTRIES INC.
B21257751
HIBCC

100
053469565 *Terms of Use
Oral Tamper Evident Cap for NeoMed 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© 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?
65823 Non-ISO80369-3-standardized oral syringe, single-use
A manual device consisting of a calibrated hollow barrel (cylinder) and a moveable plunger intended for the administration of oral medication. The tip is not formatted according to the standard for small-bore connectors for enteral applications (ISO 80369-3) [i.e., not ENFit], however the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.
Active false
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FDA Product Code

[?]
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

[?]
Size Type Text
No Device Sizes
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Device Record Status
8b091983-9f08-4372-9ea3-97e3e42a7242
April 17, 2026
5
September 23, 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
B21257752 10 B21257751 In Commercial Distribution Box
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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: B21257750 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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