BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

InPouch® TVC Subculture

DI: B08810510 · Model: 1051 · BIO-MED DIAGNOSTICS, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: InPouch® TVC Subculture
Primary DI: B08810510
Version / Model: 1051
Catalog Number: 21-051-001
Company Name: BIO-MED DIAGNOSTICS, INC.
Labeler DUNS: 605213545
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2018-09-12
Public Version: 2
Public Version Date: 2019-05-07
Public Version Status: Update
Public Device Record Key: d7da8131-cd0b-4913-aaa8-5f1b52e82ff6

Device Description

A highly selective growth medium which maintains viable Trichomonas vaginalis cultures (positive controls) for up to seven (7) days.

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSI	Culture Media, Selective And Differential	Microbiology	866.2360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B08810510	HIBCC
Package	B08810513	HIBCC	Box	10	In Commercial Distribution

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: In the dark, away from direct sunlight
Type: Storage Environment Temperature
Temperature Range: 18 – 25 Degrees Celsius