FDA.reportPublic FDA data

REMEL

Primary DI
00848838021862
Brand
REMEL
Company
REMEL, INC.
Model
R20302
Catalog number
R20302
Device description
10B Broth, Lyophilized (1.8ml) 6/PK
Published
2022-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K834065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K834065000A3BRemel Co.1983-12-27JSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838021862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838021862008488380218628488380218620848838021862

GMDN Terms#

Term, Definition table
TermDefinition
Microbiological transport medium IVDA medium in powder, liquid, broth or gel form, commonly available in a tub or bottle from which aliquots can be prepared, intended to be used to maintain the viability of microorganisms suspected of being present in a clinical specimen during its transport prior to in vitro diagnostic analysis and/or culture. It has a non-nutritive composition with or without indicator and may include types such as Amies, anaerobic, Carey-Blair, Stuart, and viral transport/inactivation mediums. This device is not a specimen collection tube/container (i.e., is not intended to directly accept a specimen), and does not include patient-contact specimen sampling/extraction devices such as swabs/brushes.

Regulatory Flags#

DUNS number
065769564
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848838018855NACP114-102016-09-24
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091827NA7115-602022-04-21
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838091834NA7116-702016-12-09
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500R7231102025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50R7231152025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18
00848838066917Liquid Stuarts,Dual Swab PK/50R7231252025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100R7231302025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50R7231352025-06-18
00848838011177Sensititre Demineralized WaterT33392023-12-21
00842558105611^CE^Liq Stuarts,Dual Swab 36mmPK/500r97231202025-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838009518REMELREMEL, INC.JSN2022-12-22
00848838021886REMELREMEL, INC.JSN2022-12-22
B08810310InPouch® TVBIO-MED DIAGNOSTICS, INC.JSN2018-08-20