Organization name

Little Sparrows Technologies, Inc.

SRN

US-MF-000040265

Manufacturer status

Active

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

• ● The bili-ruler™ is not a stand-alone diagnostic device. It is not a substitute for serum bilirubin testing. ● Use of bili-ruler™ on neonates currently undergoing phototherapy treatment or on neonates who have undergone exchange transfusions may result in misrepresentation of TcB/TSB levels. ● Do not use on infants with pathologic jaundice. ● Do not use the bili-ruler™ on broken or damaged skin. ● The neonate’s skin must be blanched for accurate readings. ● Do not clean the bili-ruler™ with ammonia or alcohol.

  OTHER

• The bili-ruler™ is not intended to be used on neonates with pathologic jaundice. If there is a possibility that the neonate is suffering from pathologic jaundice, as a result of an incompatible blood type or hemolytic jaundice, then total serum bilirubin should be measured. Do not use this device on neonates with hydrops fetalis major, congenital malformations, diseases or skin conditions or thickness that in the opinion of the physician would preclude or interfere with the use of the ruler (e.g. skin infections, purpura, etc.). Use of bili-ruler™ on neonates currently undergoing phototherapy treatment or on neonates who have undergone exchange transfusions may result in misrepresentation of TcB/TSB levels.

  OTHER

Primary placement in Netherlands; available across 32 countries total.

Trade name

bili-ruler

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.

00810101280498

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.

0810101280203JJ

Reference / catalog number

0203A

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

Neonatal Icterometer

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.

• Z12080499NEONATOLOGY INSTRUMENTS - OTHER

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.