AccessGUDID - DEVICE: Genomadix Cube CYP2C19 (G257ASM001030)

GUDID

Device Identifier (DI) Information

Brand Name: Genomadix Cube CYP2C19
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Genomadix Inc

Primary DI Number: G257ASM001030
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 204354752 *Terms of Use

Device Description: Each unit is a box of 20 swabs.

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?
65459	Oral/upper respiratory tract specimen collection swab IVD	An in vitro diagnostic device in the form of a piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for in vitro diagnostic investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTI	Drug Metabolizing Enzyme Genotyping Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220026	000

Device Exempt from Premarket Submission: No 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: 303ffe6e-b495-4811-b367-3c06ef40b3da
Public Version Date: November 28, 2024
Public Version Number: 2
DI Record Publish Date: June 14, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-888-810-7788
Email: support@genomadix.com

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