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Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name
Curaplex FDA UDI
Generic Name
Peripheral intravenous catheterization support kit FDA UDI
Device Name
IV Start Kit with Site-loc, Skin Prep, Gauze, TQ, Tape, Ext Set, Flush FDA UDI
Model / Reference
8600-01282 FDA UDI
Description
IV Start Kit with Site-loc, Skin Prep, Gauze, TQ, Tape, Ext Set, Flush FDA UDI

Identifiers

Catalog Number
8600-01282 FDA UDI
Primary DI / UDI-DI
00817617029122 FDA UDI
FDA Product Code
LRS FDA UDI
GMDN Term
Peripheral intravenous catheterization support kit 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Peripheral intravenous catheterization support kit

Curaplex by Bound Tree Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral intravenous catheterization support kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI b4b90e38-aa3f-4320-81f5-5e73cf52d4d0 34 fields · synced May 30, 2026