Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Peripheral intravenous catheterization support kit FDA UDI
- Device Name
- Curaplex Sharps Container, 8 QT FDA UDI
- Model / Reference
- 1860-08706 FDA UDI
- Description
- Curaplex Sharps Container, 8 QT FDA UDI
Identifiers
- Catalog Number
- 1860-08706 FDA UDI
- Primary DI / UDI-DI
- 00817617023168 FDA UDI
- 510(k) Number
- K942054 FDA UDI
- FDA Product Code
- MMK FDA UDI
- GMDN Term
- Peripheral intravenous catheterization support kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Peripheral intravenous catheterization support kit
Curaplex by Bound Tree Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K942054 also covers:
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- Medegen Medical Products — Medegen Medical Products
- Medegen Medical Products — Medegen Medical Products
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 2d710e0e-e9ad-4887-a334-aa644ecda54d 35 fields · synced Jun 1, 2026