FDA.reportPublic FDA data

InPouch® TV

Primary DI
B08810310
Brand
InPouch® TV
Company
BIO-MED DIAGNOSTICS, INC.
Model
1031
Catalog number
21-031-001
Device description
Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
Published
2018-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSNCulture Media, Propagating Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSNCulture Media, Propagating TransportMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896296000INPOUCH-TV POUCHBiomed Diagnostics, Inc.1990-01-29JSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B08810313PackageHIBCC10In Commercial Distribution
B08810317PackageHIBCC100In Commercial Distribution
B08810310PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective broth culture medium IVDA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00In the dark, away from direct sunlight.
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800) 964-6466info@biomeddiagnostics.com

Regulatory Flags#

DUNS number
605213545
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B088212730010InTray® SAB+PVG21272023-10-05
B08816120Saline Solution (0.85%)161211-612-0012020-09-29
B08816020VTM-C19 Transit Tube160211-602-0012020-10-05
B08815930InTray DM-FungID159321-593-0012020-02-10
B08815934InTray DM-FungID159321-593-0012020-02-10
B08824830InTray® Mueller Hinton Chocolate Agar248322-483-0012019-10-16
B08824834InTray® Mueller Hinton Chocolate Agar248322-483-0012019-10-16
B08810800InTray™ GC108010-80002016-09-21
B08812630InTray® SAB126321-263-0012018-09-12
B08815030InTray® BHI150321-503-0012018-09-12
B08810804InTray™ GC108010-80002016-09-21
B08812634InTray® SAB126321-263-0012018-09-12
B08815034InTray® BHI150321-503-0012018-09-12
B08820630InTray® DM 206322-063-0002018-09-13
B08814430InTray® TSA144321-443-0012018-09-12
B08814434InTray® TSA144321-443-0012018-09-12
B08810510InPouch® TVC Subculture105121-051-0012018-09-12
B08811030InTray® COLOREX Screen110321-103-0012018-09-13
B08811130InTray® COLOREX Yeast111321-113-0012018-09-13
B08812230InTray® COLOREX Salmonella122321-223-0012018-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838009518REMELREMEL, INC.JSN2022-12-22
00848838021862REMELREMEL, INC.JSN2022-12-22
00848838021886REMELREMEL, INC.JSN2022-12-22