FDA UDI
In Commercial Distribution
🇺🇸 United States
O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection Kit
DI: M445891081
·
Model: 891-08
·
MEDICAL CHEMICAL CORPORATION
Product Codes
3
GMDN Terms
3
Identifiers
2
Pkg Device Count
36
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Basic Information
- Brand Name
- O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection Kit
- Primary DI
- M445891081
- Version / Model
- 891-08
- Catalog Number
- 891-08
- Company Name
- MEDICAL CHEMICAL CORPORATION
- Labeler DUNS
- 008496861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- d183e885-a67b-4259-aed4-1fd408901b2c
Device Description
Convenience kit containing Zinc-PVA, SAF and C&S Vials.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | Microbiology | 866.2390 | 1 |
| IGB | Solution, Formalin-Sodium Acetate | Pathology | 864.4010 | 1 |
| LDX | Fixative, Metallic Containing | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
| 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. | No | Active |
| 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | M445891080 | HIBCC | ||||
| Primary | M445891081 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius