FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380144842
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CHB900212
Catalog number
CHB900212
Device description
SAF Stool Transport Vial
Published
2019-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
50885380144842PackageGS16In Commercial Distribution
20885380144841PrimaryGS10
10885380144844Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538014484250885380144842
2088538014484120885380144841
1088538014484410885380144844

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

Regulatory Flags#

DUNS number
961027315
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

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