FDA UDI
In Commercial Distribution
🇺🇸 United States
OMNIgene GUT Dx
DI: 00627595000507
·
Model: OMD-200
·
DNA Genotek Inc
Product Codes
1
GMDN Terms
1
Identifiers
7
Pkg Device Count
1
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Basic Information
- Brand Name
- OMNIgene GUT Dx
- Primary DI
- 00627595000507
- Version / Model
- OMD-200
- Company Name
- DNA Genotek Inc
- Labeler DUNS
- 207983508
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-18
- Public Version
- 2
- Public Version Date
- 2024-08-13
- Public Version Status
- Update
- Public Device Record Key
- 0f59a49a-b32d-435b-8eb0-da390816e1f1
Device Description
Microbial DNA Collection and Stabilization, Human Fecal Samples
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| QPO | Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples | Microbiology | 866.2952 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45967 | Faecal specimen container IVD, DNA preservation solution | A covered plastic receptacle containing a deoxyribonucleic acid (DNA) preservation solution intended to be used for the collection, preservation, and transport of DNA present in a faecal specimen for analysis and/or other investigation [e.g., evaluation for the presence of genetic markers for certain gastrointestinal cancers (e.g., colorectal, pancreatic)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00627595000774 | GS1 | OMD-200+ACP123 | 1 | Not in Commercial Distribution | 2024-01-01 |
| Primary | 00627595000507 | GS1 | ||||
| Package | 10627595000504 | GS1 | Reclosable Bag | 25 | In Commercial Distribution | |
| Package | 10627595001426 | GS1 | MP-016 | 1 | In Commercial Distribution | |
| Package | 10627595001433 | GS1 | SOF-1020 | 1 | In Commercial Distribution | |
| Package | 10627595001464 | GS1 | MP-020 | 1 | In Commercial Distribution | |
| Package | 10627595001471 | GS1 | SOF-1025 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-866-813-6354
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN200040 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius