FDA UDI
In Commercial Distribution
🇺🇸 United States
O&P Collection Vials SAF / Clean/ C&S Kits
DI: M445891051
·
Model: 891-05
·
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 SAF / Clean/ C&S Kits
- Primary DI
- M445891051
- Version / Model
- 891-05
- Catalog Number
- 891-05
- 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
- 3
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- be997848-8e48-4d02-a695-3f7c17f02a81
Device Description
Convenience kit containing SAF, Clean 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 |
|---|---|---|---|---|
| IGB | Solution, Formalin-Sodium Acetate | Pathology | 864.4010 | 1 |
| NNI | Container, Specimen, Non-Sterile | Pathology | 864.3250 | 1 |
| JSM | Culture Media, Non-Propagating Transport | Microbiology | 866.2390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | 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 | M445891050 | HIBCC | ||||
| Primary | M445891051 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius