Organization name

ZOLL Medical Corporation

SRN

US-MF-000021386

Manufacturer status

Active

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

• Consult instructions for use

Primary placement in Netherlands; available across 29 countries total.

Trade name

not provided

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.

00198843003590

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.

08479460BTCL

Reference / catalog number

777040XL-40

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

INFANT FLOW LP HEADGEAR, EXTRA LARGE, GLOBAL

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 37–42 MU10

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

• 00198843003590× 1 unitBase unit
  • 10198843003597× 10 units

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

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

• Z1203019085VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - CONSUMABLES

• Class I medical devices in EUDAMED

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