Organization name

SPM Medicare Pvt. Ltd.

SRN

IN-MF-000011829

Manufacturer status

Active

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

• Consult instructions for use
• Do not re-use
• Do not resterilize

  Do not re-sterilize

• Do not use if package is damaged
• Do not use it if the solution is cloudy or colored, contains a precipitate, or has any type of suspended particulate matter.

  OTHER

Primary placement in Austria; available across 32 countries total.

Trade name

EASY FLUSH

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.

08904379808002

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.

89043798FSHEYE

Reference / catalog number

1BV7BXD

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

Flush syringe - Pre-fillled 0.9% Normal Saline Solution-10ml(0.9% NaCl)

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 10 MU03

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

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

• A02010701PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.