AccessGUDID - DEVICE: InPouch® TV (B08810310)

GUDID

Device Identifier (DI) Information

Brand Name: InPouch® TV
Version or Model: 1031
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21-031-001
Company Name: BIO-MED DIAGNOSTICS, INC.

Primary DI Number: B08810310
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 605213545 *Terms of Use

Device Description: Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.

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):	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?
58684	Differential/selective broth culture medium IVD	A broth culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing in the same medium. It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSN	Culture Media, Propagating Transport

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K896296	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
Special Storage Condition, Specify: In the dark, away from direct sunlight.
Storage Environment Temperature: between 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bc2a11ca-9c0c-4a6d-912e-95e0037a0859
Public Version Date: May 07, 2019
Public Version Number: 2
DI Record Publish Date: August 20, 2018