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OnGuard2 Female Luer Lock Adaptor

FDA UDI

Class II (US FDA UDI)

by Simplivia Healthcare Ltd

Identity

Trade Name
OnGuard2 Female Luer Lock Adaptor FDA UDI
Generic Name
Medication transfer set FDA UDI
Device Name
OnGuard2 Female Luer Lock Adaptor a Chemfort CSTD Product The distal end connects to male luer lock The proximal end connect to Chemfort Syringe Adaptor or Chemfort Syringe Adaptor Lock FDA UDI
Model / Reference
412185 FDA UDI
Description
OnGuard2 Female Luer Lock Adaptor a Chemfort CSTD Product The distal end connects to male luer lock The proximal end connect to Chemfort Syringe Adaptor or Chemfort Syringe Adaptor Lock FDA UDI

Identifiers

Primary DI / UDI-DI
27290115921858 FDA UDI
510(k) Number
K251411 FDA UDI
FDA Product Code
ONB FDA UDI
GMDN Term
Medication transfer set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medication transfer set

OnGuard2 Female Luer Lock Adaptor by Simplivia Healthcare Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medication transfer set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Simplivia Healthcare Ltd

Sources (1)

  • FDA UDI 29b9b460-edcb-4fa8-820e-14c188da6d1e 34 fields · synced Jun 8, 2026