AccessGUDID - DEVICE: Oral Tamper Evident Cap (B2125773100RFID1)

GUDID

Device Identifier (DI) Information

Brand Name: Oral Tamper Evident Cap
Version or Model: 57-73-100 RFID
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 57-73-100 RFID
Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.

Primary DI Number: B2125773100RFID1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 053469565 *Terms of Use

Device Description: RFID OTEC – 100 units/bag, 1 bag/carton

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":	Yes
For Single-Use:	No
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?
65823	Non-ISO80369-3-standardized oral syringe	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

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: No
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: 64113047-6ab8-4c3f-9087-63a30732fd15
Public Version Date: July 20, 2023
Public Version Number: 1
DI Record Publish Date: July 12, 2023