DEVICE: Formalin / C&S / Clean Stool Collection Kits (M445891201)

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Device Record History
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Device Identifier (DI) Information
Formalin / C&S / Clean Stool Collection Kits
891-20
In Commercial Distribution
891-20
MEDICAL CHEMICAL CORPORATION
M445891201
HIBCC

36
008496861 *Terms of Use
Convenience kit containing Formalin, C&S and Clean Vials for stool collection.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
57757 10% Neutral buffered formalin IVD
A 10% neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens.
Obsolete false
58564 Carey-Blair transport medium IVD
A vessel containing transport medium intended to be used for the preservation and transport of gram negative and anaerobic microorganisms from a clinical specimen.
Obsolete false
43651 General specimen receptacle transport container
A non-powered portable device designed for the transportation of clinical specimens contained within receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of designs whereby it may be thermally insulated and might include a non-powered cold pack(s). This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IFP Formalin, Neutral Buffered
JSM Culture Media, Non-Propagating Transport
NNI Container, Specimen, Non-Sterile
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
ee97ea59-6cde-4287-8592-798ec31d1be9
December 11, 2024
2
August 31, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: M445891200 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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