FDA UDI
In Commercial Distribution
🇺🇸 United States
Medzah Genetic Testing - Saliva LC
DI: 00850070779036
·
Model: 136349
·
Medzah Industries
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Medzah Genetic Testing - Saliva LC
- Primary DI
- 00850070779036
- Version / Model
- 136349
- Company Name
- Medzah Industries
- Labeler DUNS
- 114193536
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-27
- Public Version
- 2
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- 1575df57-3484-4921-9fa6-4457f4f1ced6
Device Description
Medzah Genetic Testing - Saliva LC
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NNK | Container, Specimen Mailer And Storage, 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850070779036 | GS1 |