Identity
- Trade Name
- BD Vacutainer® PPT™ K2E 15.8 mg FDA UDI
- Generic Name
- Evacuated blood collection tube IVD, anticoagulant/separator FDA UDI
- Device Name
- TUBE PPT PLH 16X100 8.5 PLBL PWHT SNGLX FDA UDI
- Model / Reference
- 362801 FDA UDI
- Description
- TUBE PPT PLH 16X100 8.5 PLBL PWHT SNGLX FDA UDI
Identifiers
- Catalog Number
- 362801 FDA UDI
- Primary DI / UDI-DI
- 50382903628013 FDA UDI
- 510(k) Number
- K972075 FDA UDI
- FDA Product Code
- PJE FDA UDI
- GMDN Term
- Evacuated blood collection tube IVD, anticoagulant/separator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
BD Vacutainer® PPT™ K2E 15.8 mg by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 0e34ff02-c512-40e4-951e-6c0849bb9eab 37 fields · synced May 30, 2026