AccessGUDID - DEVICE: MyCare Psychiatry (00894354002311)

GUDID

Device Identifier (DI) Information

Brand Name: MyCare Psychiatry
Version or Model: MCP2-CON-US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MCP2-CON-US
Company Name: SALADAX BIOMEDICAL, INC.

Primary DI Number: 00894354002311
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 144379539 *Terms of Use

Device Description: Control Kit 2

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
55560	Clozapine IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of clozapine 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: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7a028ac6-6af6-4d1d-b055-e87f4b39c447
Public Version Date: June 16, 2022
Public Version Number: 2
DI Record Publish Date: May 15, 2020