FDA.reportPublic FDA data

Para-Pak Ultra EcoFix / C&S / Clean

Primary DI
00840733103230
Brand
Para-Pak Ultra EcoFix / C&S / Clean
Company
MERIDIAN BIOSCIENCE, INC.
Model
331612
Catalog number
331612
Device description
Para-Pak systems are convenient system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. The systems are designed for easy collection of specimens by individuals not trained in microbiological techniques and affords and excellent means of minimizing the adverse effects of delay in specimen transport.
Published
2020-12-10
Public version status
Update
Distribution status
Not 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
FMHContainer, Specimen, Sterile
JSMCulture Media, Non-Propagating Transport
LDXFixative, Metallic Containing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1
JSMCulture Media, Non-Propagating TransportMicrobiology1
LDXFixative, Metallic ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733103230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733103230008407331032308407331032300840733103230

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen container IVD, transport bufferA covered plastic receptacle containing transport buffer solution intended to be used for the collection, preservation, and transport of faecal specimen for culture, analysis, and/or other investigation. 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
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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

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