Organization name

Interrad Medical, Inc.

SRN

US-MF-000009878

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• Do not re-use

  Do not re-use. Intended for Single Patient Use. DO NOT REUSE. Reuse may lead to SAE and device malfunction.

• Biological risks

  After use, this product may be a potentail biohazard. Handle and discard in accordance with accepted medical practice and applicable local, state and federal laws and regulations.

• EUH 208 – Contains (name of sensitising substance). May produce an allergic reaction.

  Contains Nickel

Primary placement in XI; available across 27 countries total.

Trade name

SecurAcath

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00865382000297

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

08653820002400XXXG5

Reference / catalog number

400180

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Subcutaneous catheter securement system

Additional information URL

https://securacath.com/ifu/

Clinical sizes

• 10 MU170

1 packaging level registered — each level carries its own UDI-DI.

• 00865382000297× 1 unitBase unit
  • 10865382000294× 10 units

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• C010180PERIPHERAL I.V. CATHETERS AND CANNULAS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
• C010299CENTRAL VENOUS CATHETERS - OTHER
• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

• 28620239803Issued
  Technical documentationNotified body: Intertek Medical Notified Body AB (2862)Expiry: Dec 18, 2029