DEVICE: O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection Kit (M445891081)
Device Identifier (DI) Information
O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection Kit
891-08
In Commercial Distribution
891-08
MEDICAL CHEMICAL CORPORATION
891-08
In Commercial Distribution
891-08
MEDICAL CHEMICAL CORPORATION
Convenience kit containing Zinc-PVA, SAF and C&S Vials.
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? |
|---|---|---|---|---|
| 57910 | Faecal specimen container IVD, fixative |
A 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.
|
Active | 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 |
| 33832 | Fixative, metallic |
An agent containing metal employed in the preparation of a histologic or pathologic human specimen for the purpose of maintaining the existing form and structure of all of its constituent elements to be used for general diagnostic applications.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| JSM | Culture Media, Non-Propagating Transport |
| IGB | Solution, Formalin-Sodium Acetate |
| LDX | Fixative, Metallic Containing |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
d183e885-a67b-4259-aed4-1fd408901b2c
June 10, 2022
2
August 31, 2020
June 10, 2022
2
August 31, 2020
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
M445891080
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined