FDA.reportPublic FDA data

Para-Pak CLEAN

Primary DI
00840733103322
Brand
Para-Pak CLEAN
Company
MERIDIAN BIOSCIENCE, INC.
Model
9003-01
Catalog number
900312
Device description
Device for the collection, transportation, preservation and examination of stool specimens containing intestinal parasites
Published
2021-06-18
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
FHMApparatus, Suturing, Stomach And Intestinal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHMApparatus, Suturing, Stomach And IntestinalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733103322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733103322008407331033228407331033220840733103322

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen container IVD, no additiveA covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a faecal specimen for culture, analysis, and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
092815364
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
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

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10884521048997TA PremiumCovidien LPFHM2018-08-10
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10884521049024TA 90 BNCovidien LPFHM2018-08-10
20884521031637GIA PremiumCovidien LPFHM2018-08-10
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00613994941770Pro-Flo™MEDTRONIC, INC.FHM2016-06-13
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