AccessGUDID - DEVICE: DIGITOXIN PLUS LEVEL 1 (B800DIGO1SLC0)

GUDID

Device Identifier (DI) Information

Brand Name: DIGITOXIN PLUS LEVEL 1
Version or Model: DIGO+ 1 S LC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DIGO+ 1 S LC
Company Name: UTAK LABORATORIES, INC.

Primary DI Number: B800DIGO1SLC0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092519016 *Terms of Use

Device Description: DIGITOXIN PLUS LEVEL 1

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:	No
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?
55235	Multiple-therapy therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	Drug Specific Control Materials

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: less than -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: cd0ef659-1bd7-43ff-917f-4559f7e3e64f
Public Version Date: January 31, 2023
Public Version Number: 1
DI Record Publish Date: January 23, 2023