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
Primary Device IDB08810310
NIH Device Record Keybc2a11ca-9c0c-4a6d-912e-95e0037a0859
Commercial Distribution StatusIn Commercial Distribution
Brand NameInPouch® TV
Version Model Number1031
Catalog Number21-031-001
Company DUNS605213545
Company NameBIO-MED DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800) 964-6466
Emailinfo@biomeddiagnostics.com
Phone+1(800) 964-6466
Emailinfo@biomeddiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB08810310 [Primary]
HIBCCB08810313 [Package]
Package: Box [10 Units]
In Commercial Distribution
HIBCCB08810317 [Package]
Package: Box [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSNCulture Media, Propagating Transport

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-07
Device Publish Date2018-08-20

Devices Manufactured by BIO-MED DIAGNOSTICS, INC.

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Trademark Results [InPouch]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INPOUCH
INPOUCH
87218425 5214087 Live/Registered
Bio-Med Diagnostics, Inc.
2016-10-27

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