Normal Saline for irrigation Grifols

Organization name

Laboratorios Grifols S.A.

SRN

ES-MF-000000767

Manufacturer status

Active

D-ESMF000000767725061UN

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

1 warning recorded — scroll inside the panel to see all entries.

• - The solutions for irrigation Grifols must not be injected. - The preparation should be used only once. Any solution fraction should be discarded. - It contains phthalate, hence precaution should be maximised in at risk populations. - There is limited evidence on the relationship between exposure to DEHP and its adverse effects on humans, although it may eventually produce effects on the development and the reproductive system. - The product reuse poses risk of infection.

  OTHER

Primary placement in Spain; available across 2 countries total.

Trade name

Normal Saline for irrigation Grifols

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.

D-ESMF000000767725061UN

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.

B-ESMF000000767725061UN

Reference / catalog number

725061

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.

EUDAMED

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 IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The product NORMAL SALINE FOR IRRIGATION GRIFOLS is an isotonic, sterile and non-pyrogenic 0.9% sodium chloride solution, indicated in the endoscopic transurethral procedures that require the distension and irrigation of the urinary bladder. It consists of a poly(vinyl chloride) (PVC) bag of 3000 ml closed with a polycarbonate connector with a butyl rubber stopper.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• U0380DEVICES FOR URINARY TRACT DILATION - ACCESSORIES

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

No certificate specifically references this device's Basic UDI-DI.