FDA UDI
In Commercial Distribution
🇺🇸 United States
TransFix/EDTA Vacuum Blood Collection Tube
DI: 05060531711603
·
Model: KC1030
·
CALTAG MEDSYSTEMS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- TransFix/EDTA Vacuum Blood Collection Tube
- Primary DI
- 05060531711603
- Version / Model
- KC1030
- Catalog Number
- TVT-03-50
- Company Name
- CALTAG MEDSYSTEMS LIMITED
- Labeler DUNS
- 221434843
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-20
- Public Version
- 2
- Public Version Date
- 2023-06-29
- Public Version Status
- Update
- Public Device Record Key
- 1d21a5f5-5a41-4037-be30-22492f89cea5
Device Description
TransFix/EDTA Vacuum Blood Collection Tube to directly draw and stabilize whole blood for flow cytometric analysis.
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| GIM | Tubes, Vacuum Sample, With Anticoagulant | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64508 | Evacuated blood collection tube IVD, anticoagulant/cell preservative | A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), sodium heparin, sodium citrate, potassium oxalate], and a preservative which stabilizes cell morphology and cell marker expression. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., flow cytometry analysis of white blood cells]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15060531711600 | GS1 | Foil Pouch | 50 | In Commercial Distribution | |
| Primary | 05060531711603 | GS1 | ||||
| Package | 45060531711601 | GS1 | Foil Pouch | 2 | In Commercial Distribution | |
| Previous | 05060531711627 | GS1 | ||||
| Package | 35060531711604 | GS1 | Foil Pouch | 1 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius