FDA UDI
In Commercial Distribution
🇺🇸 United States
PAXgene® Blood DNA Tube
DI: 04053727611659
·
Model: 761165
·
PreAnalytiX GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PAXgene® Blood DNA Tube
- Primary DI
- 04053727611659
- Version / Model
- 761165
- Catalog Number
- 761165
- Company Name
- PreAnalytiX GmbH
- Labeler DUNS
- 480915029
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-28
- Public Version
- 3
- Public Version Date
- 2023-11-09
- Public Version Status
- Update
- Public Device Record Key
- dfdc9d7c-12c5-4ac7-b3ce-0a2e8bceb0cf
Device Description
PAX DNA IVD BLOOD COLLECTION TUBE
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PJE | Blood/plasma collection device for DNA testing | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63121 | Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer | A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant agent [e.g., tripotassium ethylene diamine tetraacetic acid (K3EDTA)], and a nucleic acid (DNA/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 | 04053727611659 | GS1 | ||||
| Package | 54053727611654 | GS1 | Case | 1000 | In Commercial Distribution | |
| Package | 34053727611650 | GS1 | Shelfpack | 100 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231469 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature