O&P Collection Vials SAF / Clean/ C&S Kits 891-05

GUDID M445891050

Convenience kit containing SAF, Clean and C&S Vials.

MEDICAL CHEMICAL CORPORATION

Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, sodium acetate/acetic acid/formaldehyde (SAF) fixative Faecal specimen container IVD, fixative Faecal specimen container IVD, fixative Faecal specimen container IVD, fixative Faecal specimen container IVD, fixative Faecal specimen container IVD, fixative Faecal specimen container IVD, fixative
Primary Device IDM445891050
NIH Device Record Keybe997848-8e48-4d02-a695-3f7c17f02a81
Commercial Distribution StatusIn Commercial Distribution
Brand NameO&P Collection Vials SAF / Clean/ C&S Kits
Version Model Number891-05
Catalog Number891-05
Company DUNS008496861
Company NameMEDICAL CHEMICAL CORPORATION
Device Count36
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM445891050 [Unit of Use]
HIBCCM445891051 [Primary]

FDA Product Code

IGBSolution, Formalin-Sodium Acetate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-08
Device Publish Date2020-08-31

Devices Manufactured by MEDICAL CHEMICAL CORPORATION

M445693A50PACK1 - SED-CONNECT2021-07-08 SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. Thi
M445693AESEDEA50PACK1 - SED-CONNECT2021-07-08 SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. Thi
M445693AFUNNEL1 - SED-CONNECT2021-07-08 SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. Thi
M445693ASAMPLE1 - SED-CONNECT2021-07-08 SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. Thi
M445694A1 - MICRO-SED2021-07-08 SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. Thi
M445694AEA1 - MICRO-SED2021-07-08 MICRO-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This
M445694ASAMPLE1 - MICRO-SED2021-07-08 MICRO-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This
M445694ATUBEFUNNEL1 - MICRO-SED2021-07-08 MICRO-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This
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