Curaplex

FDA UDI

Class II (US FDA UDI)

by Bound Tree Medical, Llc

Identity

Trade Name: Curaplex FDA UDI
Generic Name: Intravenous line recessed-needle connector FDA UDI
Device Name: IV Catheter, ClearSafe, 16 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs FDA UDI
Model / Reference: 1612-84120 FDA UDI
Description: IV Catheter, ClearSafe, 16 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs FDA UDI

Identifiers

Primary DI / UDI-DI: 00815277023382 FDA UDI
FDA Product Code: FOZ FDA UDI
GMDN Term: Intravenous line recessed-needle connector 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 16 Gauge FDA UDI

Category: Intravenous line recessed-needle connector

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

Similar devices

Also classified as Intravenous line recessed-needle connector.

Smith's Catheters — MEDSOURCE INTERNATIONAL LLC · Class II
MedSource TrueSafe Comfort Safety IV Catheter 18g 1.88" — MEDSOURCE INTERNATIONAL LLC · Class II
MedSource Catheters — MEDSOURCE INTERNATIONAL LLC · Class II
Henry Schein Safety IV Catheter 20G x 1.88 — MEDSOURCE INTERNATIONAL LLC · Class II
Smith's Catheters — MEDSOURCE INTERNATIONAL LLC · Class II
Smith's Catheters — MEDSOURCE INTERNATIONAL LLC · Class II
MedSource Catheters — MEDSOURCE INTERNATIONAL LLC · Class II
MedSource TrueSafe Safety IV Catheter 22g 1.00" — MEDSOURCE INTERNATIONAL LLC · 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 8369ac81-cf07-46ed-81e4-3c6a3fe2660a 34 fields · synced Jun 8, 2026