Organization name

SINAPI Biomedical (Pty) Ltd

SRN

ZA-MF-000012126

Manufacturer status

Active

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

• Do not re-use

  Single use only

• Do not use if package is damaged

  Do not use if the package is broken

• Caution

  1. This device is only intended for use by appropriately trained personnel. 2. Suction must be reinstated once the drainage bag has been disconnected. 3. Observing Universal Precautions, discard the drainage bag as medical waste in accordance with the Waste Management policy of the health care facility. 4. NOTE: Any serious incident that occurs in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Primary placement in Poland; available across 14 countries total.

Trade name

Sinapi Collection container

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.

06009900386751

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.

60099003867SCCW3

Reference / catalog number

D001

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The SINAPI drainage bag is a non-sterile, single use adjunct to the Sinapi XL1000/S/SC and XL200/S/SC chest drain models. The contents of the Sinapi Chest Drain (SCD) are emptied into the drainage bag and discarded.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• 06009900386751× 1 unitBase unit
  • 16009900386758× 30 units
  • 26009900386755× 240 units

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

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

• A0680DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.