FDA.reportPublic FDA data

REMEL

Primary DI
00848838031267
Brand
REMEL
Company
REMEL, INC.
Model
R40036
Catalog number
R40036
Device description
Schaudinn's Fixative BTL/500ml
Published
2022-12-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IFQFormulations, Mercuric Chloride For Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IFQFormulations, Mercuric Chloride For TissuePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838031267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838031267008488380312678488380312670848838031267

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen container IVD, fixativeA covered plastic receptacle containing a fixative solution [e.g., sodium acetate, acetic acid and/or formaldehyde (SAF), Schaudinn’s, polyvinyl alcohol (PVA) or acid alcohol] intended to be used for the collection, and preservation and/or transport, of a faecal specimen for analysis and/or other investigation [e.g., evaluation for the presence of intestinal parasites and/or their eggs (ova)]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065769564
Device count
1
Premarket exempt
true
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
00840733103025Para-Pak Modified (Cu) PVAMERIDIAN BIOSCIENCE, INC.IFQ2023-10-17
00840733103292Para-Pak LV-PVAMERIDIAN BIOSCIENCE, INC.IFQ2021-07-06
00840733103315Para-Pak LV-PVAMERIDIAN BIOSCIENCE, INC.IFQ2021-07-06
00840733102806Para-Pak LV-PVA / 10% Formalin / C&SMERIDIAN BIOSCIENCE, INC.IFQ2020-12-10
00840733102936Para-Pak LV-PVA / 10% Formalin / CleanMERIDIAN BIOSCIENCE, INC.IFQ2020-12-10
00840733102967Para-Pak LV-PVA / Ultra 10% FormalinMERIDIAN BIOSCIENCE, INC.IFQ2020-12-10
00840733103032Para-Pak Modified (Cu) PVA/FormalinMERIDIAN BIOSCIENCE, INC.IFQ2020-12-10
00840733103049Para-Pak Modified (Cu) PVA/FormalinMERIDIAN BIOSCIENCE, INC.IFQ2020-12-10
00840733103063Para-Pak LV-PVA / Ultra 10% FormalinMERIDIAN BIOSCIENCE, INC.IFQ2020-12-10
00840733103070Para-Pak LV-PVA / 10% Formalin / CleanMERIDIAN BIOSCIENCE, INC.IFQ2020-12-10
00840733103094Para-Pak LV-PVA / 10% Formalin / C&SMERIDIAN BIOSCIENCE, INC.IFQ2020-12-10
00840733102448Para-Pak LV-PVAMERIDIAN BIOSCIENCE, INC.IFQ2020-12-09
00840733102608Para-Pak LV-PVA / 10% Formalin MERIDIAN BIOSCIENCE, INC.IFQ2020-11-17
20885380144834CARDINAL HEALTHCardinal Health 200, LLCIFQ2019-08-21