FDA UDI
In Commercial Distribution
🇺🇸 United States
BAPA tube for T-TAS 01
DI: 04589448510051
·
Model: N/A
·
ZACROS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BAPA tube for T-TAS 01
- Primary DI
- 04589448510051
- Version / Model
- N/A
- Catalog Number
- 18004
- Company Name
- ZACROS CORPORATION
- Labeler DUNS
- 690584370
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-12
- Public Version
- 1
- Public Version Date
- 2024-12-20
- Public Version Status
- New
- Public Device Record Key
- eea95e7f-3ab9-4c4c-894d-bd60e2695c6c
Device Description
Blood collection tube containing BAPA anticoagulant for use with the PL Chip for T-TAS 01, 50/pack
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
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOZ | System, Automated Platelet Aggregation | Hematology | 864.5700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47592 | Evacuated blood collection tube IVD, anticoagulant | A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and an anticoagulant [e.g., sodium heparin, sodium citrate, potassium oxalate, ethylenediaminetetraacetic acid (EDTA)]. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood lead, toxicology, nutritional-chemistry, and other plasma chemistry determinations). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04589448510051 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191364 | 000 |