AccessGUDID - DEVICE: Doselogix (00813360023622)

GUDID

Device Identifier (DI) Information

Brand Name: Doselogix
Version or Model: TC9-R-LIGHTSAFE 6.5ML Micro
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 755630
Company Name: TEAM TECHNOLOGIES, INC.

Primary DI Number: 00813360023622
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078550672 *Terms of Use

Device Description: TC9-R-LIGHTSAFE 6.5ML Micro

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
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?
12505	Medicine cup, single-use	A cup specially designed for administering medicine to patients or disabled persons. It is made of disposable plastic and will typically have graduated markings to facilitate providing specific doses of medication. It may be used both for tablets and fluids. 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
Storage Environment Temperature: between 35 and 160 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cd36b35c-2a2b-4b3f-beed-b65f941a7807
Public Version Date: August 21, 2024
Public Version Number: 1
DI Record Publish Date: August 13, 2024