FDA.reportPublic FDA data

Para-Pak Modified (Cu) PVA

Primary DI
00840733103025
Brand
Para-Pak Modified (Cu) PVA
Company
MERIDIAN BIOSCIENCE, INC.
Model
9005
Device description
Para-Pak based systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transportation.
Published
2023-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00840733103025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733103025008407331030258407331030250840733103025

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-343-3858MBI-TechService@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840733101595StatID PRO COVID/Flu A&B Swabs7831107831102026-05-14
00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
00840733101717PREMIER CAMPY6180966180962020-09-01
00840733101397Fungal Immunodiffusion Plates - 4 Series1010091010092019-11-21
00840733101403Fungal Immunodiffusion Plates - 1 Series1010121010122019-11-21
00840733101014ANA Screen ELISA Test Kit488426148842612016-09-23
00840733102585Hemo-De8013008013002020-12-09
00840733102660Modified Hemo-De8016008016002020-09-21
00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838031267REMELREMEL, INC.IFQ2022-12-23
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