FDA UDI
In Commercial Distribution
🇺🇸 United States
O&P Collection Vials Formalin/C&S Kits
DI: M445890211
·
Model: 890-21
·
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 Formalin/C&S Kits
- Primary DI
- M445890211
- Version / Model
- 890-21
- Catalog Number
- 890-21
- 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
- 1
- Public Version Date
- 2020-09-08
- Public Version Status
- New
- Public Device Record Key
- d4bbdcda-23e2-4a59-b971-f518c7faa71e
Device Description
Convenience kit containing C&S Vials and Buffered Formalin 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 |
|---|---|---|---|---|
| IFP | Formalin, Neutral Buffered | Pathology | 864.4010 | 1 |
| JSM | Culture Media, Non-Propagating Transport | Microbiology | 866.2390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Obsolete |
| 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 | M445890210 | HIBCC | ||||
| Primary | M445890211 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius