InPouch® TV 21-031-001

GUDID B08810310

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

BIO-MED DIAGNOSTICS, INC.

Differential/selective broth culture medium IVD Differential/selective broth culture medium IVD

• Primary Device ID: B08810310
• NIH Device Record Key: bc2a11ca-9c0c-4a6d-912e-95e0037a0859
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InPouch® TV
• Version Model Number: 1031
• Catalog Number: 21-031-001
• Company DUNS: 605213545
• Company Name: BIO-MED DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800) 964-6466
• Email: info@biomeddiagnostics.com
• Phone: +1(800) 964-6466
• Email: info@biomeddiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B08810310 [Primary]
HIBCC	B08810313 [Package]; Package: Box [10 Units]; In Commercial Distribution
HIBCC	B08810317 [Package]; Package: Box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896296

FDA Product Code

• JSN: Culture Media, Propagating Transport

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-07
• Device Publish Date: 2018-08-20

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