FDA.reportPublic FDA data

Para-Pak Ultra SAF

Primary DI
00840733102455
Brand
Para-Pak Ultra SAF
Company
MERIDIAN BIOSCIENCE, INC.
Model
980212
Catalog number
980212
Device description
The Para-Pak Ultra SAF is a convenient system for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
Published
2020-12-09
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
IGGFormaldehyde (Formalin, Formol)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IGGFormaldehyde (Formalin, Formol)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733102455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733102455008407331024558407331024550840733102455

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixativeA covered plastic receptacle containing sodium acetate, acetic acid and/or formaldehyde (SAF) fixative solution intended to be used for the collection, and preservation and/or transport, of a faecal specimen for 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
513-271-3700info@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
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09
00840733102493Para-Pak Ultra EcoFix9813129813122020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733103469Para-Pak SAF (Genova Diagnostics)MERIDIAN BIOSCIENCE, INC.IGG2021-10-27
00840733103377Para-Pak ULTRA 10% FormalinMERIDIAN BIOSCIENCE, INC.IGG2021-10-14
00840733102486Para-Pak SAFMERIDIAN BIOSCIENCE, INC.IGG2021-07-06
00840733103360Para-Pak Ultra SAFMERIDIAN BIOSCIENCE, INC.IGG2021-07-06
00840733103391Para-Pak 10% Formalin FixativeMERIDIAN BIOSCIENCE, INC.IGG2021-06-18
00840733101250Para-Pak Zn-PVA / 10% FormalinMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102615Para-Pak Zn-PVA / 10% Formalin MERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102806Para-Pak LV-PVA / 10% Formalin / C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102813Para-Pak Zn-PVA / 10% Formalin / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102820Para-Pak Zn-PVA / 10% Formalin / C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102936Para-Pak LV-PVA / 10% Formalin / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102943Para-Pak SAF/C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102950Para-Pak SAF / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102967Para-Pak LV-PVA / Ultra 10% FormalinMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102981Para-Pak Ultra SAF / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733102998Para-Pak Zn-PVA / Ultra 10% FormalinMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103001Para-Pak SAF/C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103032Para-Pak Modified (Cu) PVA/FormalinMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103049Para-Pak Modified (Cu) PVA/FormalinMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103063Para-Pak LV-PVA / Ultra 10% FormalinMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103070Para-Pak LV-PVA / 10% Formalin / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103087Para-Pak SAF / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103094Para-Pak LV-PVA / 10% Formalin / C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103100Para-Pak Zn-PVA / 10% Formalin / CleanMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103131Para-Pak ULTRA SAF Fixative / Clean VialMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103148Para-Pak Zn-PVA/Ultra 10% Formalin MERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103179Para-Pak Zn-PVA / 10% Formalin / C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103209Para-Pak SAF / Clean / C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103216Para-Pak SAF / Clean / C&SMERIDIAN BIOSCIENCE, INC.IGG2020-12-10
00840733103261Para-Pak C&S/Ultra 10%/Clean MERIDIAN BIOSCIENCE, INC.IGG2020-12-10