Identity
- Trade Name
- IV Plus® FDA UDI
- Generic Name
- Luer-ended blood collection tube spike FDA UDI
- Device Name
- Blood Collection Assembly with Male Luer Lock FDA UDI
- Model / Reference
- BD6010 FDA UDI
- Description
- Blood Collection Assembly with Male Luer Lock FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10815879021011 FDA UDI
- FDA Product Code
- KST FDA UDI
- GMDN Term
- Luer-ended blood collection tube spike FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9125 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: Luer-ended blood collection tube spike
IV Plus® by Nexus Medical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Luer-ended blood collection tube spike.
- SURSHIELD — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
- Vacuette — Greiner Bio-One GmbH · Class II
- Vacuette — Greiner Bio-One GmbH · Class I
- Medex — ICU MEDICAL, INC. · Class I
- Multi-Sampling Connector — Fresenius Kabi · Class I
- SURSHIELD — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
- Vacuette — Greiner Bio-One GmbH · Class II
- Blood Culture Adapter — Sarstedt Aktiengesellschaft & Co.KG · 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
- Nexus Medical, LLC
Sources (1)
- FDA UDI ffae070e-5fb2-477a-8408-774e2976cfdf 34 fields · synced May 31, 2026