FDA UDI
In Commercial Distribution
🇺🇸 United States
O&P Collection Vials C&S/Clean Kits
DI: M445890151
·
Model: 890-15
·
MEDICAL CHEMICAL CORPORATION
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- O&P Collection Vials C&S/Clean Kits
- Primary DI
- M445890151
- Version / Model
- 890-15
- Catalog Number
- 890-15
- Company Name
- MEDICAL CHEMICAL CORPORATION
- Labeler DUNS
- 008496861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 2
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- abbb82d5-7af9-41f8-b974-ffec60e0a75b
Device Description
Convenience kit containing C&S Vials and Clean 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 |
| NNI | Container, Specimen, Non-Sterile | Pathology | 864.3250 | 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 |
| 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 | M445890150 | HIBCC | ||||
| Primary | M445890151 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius