FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Vacutainer® PPT™ K2E 15.8 mg
DI: 50382903628013
·
Model: 362801
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- BD Vacutainer® PPT™ K2E 15.8 mg
- Primary DI
- 50382903628013
- Version / Model
- 362801
- Catalog Number
- 362801
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2016-07-28
- Public Version
- 4
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 0e34ff02-c512-40e4-951e-6c0849bb9eab
Device Description
BD Vacutainer® PPT™ K2E 15.8 mg
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 |
|---|---|---|---|---|
| 47587 | Evacuated blood collection tube IVD, anticoagulant/separator | 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 separator (e.g., gel) to separate blood plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., testing plasma in molecular diagnostics and viral load detection). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 50382903628013 | GS1 | ||||
| Unit of Use | 00382903628018 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K972075 | 000 |