O&P Collection Vials SAF / Clean/ C&S Kits

Primary DI
M445891050
Brand
O&P Collection Vials SAF / Clean/ C&S Kits
Company
MEDICAL CHEMICAL CORPORATION
Model
891-05
Catalog number
891-05
Device description
Convenience kit containing SAF, Clean and C&S Vials.
Published
2020-08-31
Public version status
New
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
IGBSolution, Formalin-Sodium Acetate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IGBSolution, Formalin-Sodium AcetatePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M445891051PrimaryHIBCC0
M445891050Unit of UseHIBCC0

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

Regulatory Flags#

DUNS number
008496861
Device count
36
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M445890151O&P Collection Vials C&S/Clean Kits890-15890-152020-08-31
M445891051O&P Collection Vials SAF / Clean/ C&S Kits891-05891-052020-08-31
M445891101Unifix / Clean / C&S Kits O&P Collection Vials891-10891-102020-08-31
M445891171Total-Fix / C&S / Clean O&P Collection Kits891-17891-172020-08-31
M44589117ORNGE1Total-Fix / C&S / Clean O&P Collection Kits891-17_ORNGE891-17_ORNGE2020-08-31
M445891201Formalin / C&S / Clean Stool Collection Kits891-20891-202020-08-31
M445892021Total-Fix / Formalin / C&S / Clean O&P Collection Kits892-02892-022020-08-31
M445892031Z-PVA / Formalin / C&S / Clean O&P Collection Kits892-03892-032020-08-31
M445892030Z-PVA / Formalin / C&S / Clean O&P Collection Kits892-03892-032020-08-31
M4454505K1Bone Marrow Kit4505K4505K2020-09-09
M445891081O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection Kit891-08891-082020-08-31
M445693A50PACK1SED-CONNECT693A 50 PACK693A 50 PACK2016-09-20
M445693AESEDEA50PACK1SED-CONNECT693A-E SED+EA693A-E SED+EA2016-09-20
M445693AFUNNEL1SED-CONNECT693A-FUNNEL693A-FUNNEL2016-09-20
M445693ASAMPLE1SED-CONNECT693A-Sample693A-Sample2016-09-20
M445694A1MICRO-SED694A694A2016-09-20
M445694AEA1MICRO-SED694A-EA694A-EA2016-09-20
M445694ASAMPLE1MICRO-SED694A-Sample694A-Sample2016-09-20
M445694ATUBEFUNNEL1MICRO-SED694A-TUBE/FUNNEL 1000694A-TUBE/FUNNEL 10002016-09-20
M445695A1PARA-SED695A695A2016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838024214REMELREMEL, INC.IGB2022-12-23
00848838024221REMELREMEL, INC.IGB2022-12-23
00848838024375REMELREMEL, INC.IGB2022-12-23
00816085022260Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-11
00816085022154Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-10
00816085022550Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-10
00816085022666Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-10
00816085022833Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-10
M445891051O&P Collection Vials SAF / Clean/ C&S KitsMEDICAL CHEMICAL CORPORATIONIGB2020-08-31
M445891081O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection KitMEDICAL CHEMICAL CORPORATIONIGB2020-08-31