Identity
- Trade Name
- Curaplex® FDA UDI
- Generic Name
- Basic intravenous administration set, invasive FDA UDI
- Device Name
- *CUSTOM* UH IV Start Kit FDA UDI
- Model / Reference
- 8600-01518 FDA UDI
- Description
- *CUSTOM* UH IV Start Kit FDA UDI
Identifiers
- Catalog Number
- 8600-01518 FDA UDI
- Primary DI / UDI-DI
- 00810094577186 FDA UDI
- FDA Product Code
- LRS FDA UDI
- GMDN Term
- Basic intravenous administration set, invasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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: Basic intravenous administration set, invasive
Curaplex® by Bound Tree Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Basic intravenous administration set, invasive.
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- SURFLO — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
- SURFLO™ — Terumo Europe NV · Class II
- VACUETTE — Greiner Bio-One GmbH · Class II
- ULTRAFLO-R — Innovative Medical Technologies, Inc. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI 53e7a4b4-9937-4dfc-969d-f8fcbfe3cd33 34 fields · synced Jun 8, 2026