FDA UDI
In Commercial Distribution
🇺🇸 United States
PAXgene® Blood RNA Tube
DI: 04053727621658
·
Model: 762165
·
PreAnalytiX GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PAXgene® Blood RNA Tube
- Primary DI
- 04053727621658
- Version / Model
- 762165
- Catalog Number
- 762165
- Company Name
- PreAnalytiX GmbH
- Labeler DUNS
- 480915029
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-25
- Public Version
- 6
- Public Version Date
- 2025-12-16
- Public Version Status
- Update
- Public Device Record Key
- 07165ec7-f598-413f-9e9f-5ea6ce8eaf03
Device Description
TUBE RNA PLH 16X100 2.5 PLBLCE CLR
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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NTW | System, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test | Immunology | 866.4070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57898 | Evacuated blood collection tube IVD, nucleic acid stabilizer | A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and a nucleic acid [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] stabilizer. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04053727621658 | GS1 | ||||
| Package | 54053727621653 | GS1 | Case | 100 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 100 | Millimeter | |
| Total Volume | 2.5 | Milliliter | |
| Device Size Text, specify | Diameter = 16 millimetre (mm) |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- This way up
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care