Identity
- Trade Name
- BLOOD SAMPLE CONCENTRATOR KIT FDA UDI
- Generic Name
- Fluid transfer tube, general-purpose FDA UDI
- Model / Reference
- KIT BSC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435389815570 FDA UDI
- FDA Product Code
- JJH FDA UDI
- GMDN Term
- Fluid transfer tube, general-purpose FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fluid transfer tube, general-purpose
Blood Sample Concentrator Kit by Biotechnology Institute Sl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluid transfer tube, general-purpose.
- Y-type Irrigation Set — Suzhou AcuVu Medical Technology Co., Ltd. · Class I
- Cook — COOK INCORPORATED · Class II
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Y-type Irrigation Set with 3-way Stopcock — Suzhou AcuVu Medical Technology Co., Ltd. · Class I
- Labcath — COOK INCORPORATED · Class I
- Cook — COOK INCORPORATED · Class II
- Disposable fluid tube — Suzhou AcuVu Medical Technology Co., Ltd. · Class I
- Cook — COOK INCORPORATED · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biotechnology Institute Sl
Sources (1)
- FDA UDI 50aea5ab-76e8-487a-a9be-b98596f456aa 32 fields · synced May 30, 2026