FDA UDI
In Commercial Distribution
🇺🇸 United States
InActiv Blue
DI: 05411967003464
·
Model: IB_TUB
·
Fertipro NV
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- InActiv Blue
- Primary DI
- 05411967003464
- Version / Model
- IB_TUB
- Company Name
- Fertipro NV
- Labeler DUNS
- 373904101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-14
- Public Version
- 1
- Public Version Date
- 2024-08-22
- Public Version Status
- New
- Public Device Record Key
- e76f535c-18e9-469b-93b8-1b19a1401b93
Device Description
InActiv Blue is a pathogen-inactivating and DNA/RNA stabilizing medium used for transport of naso- or oropharyngeal swabs, or saliva sampled from patients for in vitro diagnostic testing on the presence of genetic material of a virus by RT-qPCR or other molecular method (SARS-CoV-2, Influenza A/B, RSV A/B).
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 |
|---|---|---|---|---|
| QBD | Microbial Nucleic Acid Storage And Stabilization Device | Microbiology | 866.2950 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62392 | Oral/respiratory tract specimen container IVD, additive/medium | A covered receptacle containing an additive and/or medium [e.g., saline, sodium azide, buffer solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)] intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation (e.g., COVID-19 screening). It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05411967003471 | GS1 | Rack | 50 | In Commercial Distribution | |
| Primary | 05411967003464 | GS1 | ||||
| Package | 05411967003778 | GS1 | Carboard box | 400 | In Commercial Distribution | |
| Package | 05411967003488 | GS1 | Carboard box | 1200 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221547 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 2 | Milliliter |