AccessGUDID - DEVICE: Oral Tamper Evident Cap (B212ISOTECOR1)

GUDID

Device Identifier (DI) Information

Brand Name: Oral Tamper Evident Cap
Version or Model: ISOTEC-OR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ISOTEC-OR
Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.

Primary DI Number: B212ISOTECOR1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 053469565 *Terms of Use

Device Description: Oral Tamper Evident Cap for Baxter / ExactaMed Oral Dispenser. Non-Sterile, Bag of 100, Box of 1000. Provides Evidence of Access and Positive Closure

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35754	Oral liquid dose dispenser cabinet	An electrically-powered 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 with an electronic pump that contains unit-dose packaged liquid drugs (e.g., glass ampules, sealed plastic containers) and/or containers with multiple doses that dispense an exact amount of liquid at a time.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYX	Dispenser, Liquid Medication

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e01345d7-ca9d-4a49-b9b8-61bd1c4260dc
Public Version Date: October 29, 2021
Public Version Number: 3
DI Record Publish Date: October 14, 2016