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Organization name
UDI-DI code
Reference / catalog number

Pressure Infusion Bag — Class I MDR by NOXA MEDICAL OÜ

MD Atlas
NOXA MEDICAL OÜ

EUDAMED last updated this device on Jun 25, 2024

Pressure Infusion Bag

47450110397NCZP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NOXA MEDICAL OÜ
UDI-DI code: 04745011039729
Reference / catalog number: 500ml,1000ml,3000ml, 5000ml

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Manufacturer information

Organization name: NOXA MEDICAL OÜ
SRN: EE-MF-000042213
Manufacturer status: Active

Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Jun 1, 2024	Dec 31, 2029
Estonia	Jun 1, 2024	Dec 31, 2029

Device identification

Trade name: Pressure Infusion Bag
UDI-DI code: 04745011039729
Basic UDI-DI: 47450110397NCZP
Reference / catalog number: 500ml,1000ml,3000ml, 5000ml
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The pressure infusion bags is a manually operated device that increases/controls the rate of intravenous (IV) solution to the patient by manually applying pressure directly to the infusion bag. It is usually a flexible inflatable bag with a pocket to hold the infusion bag; Pressure is generated by squeezing the ball. This is a reusable device.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A0303RAPID INFUSION SYSTEMS (HIGH FLOW)

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Pressure Infusion BagB-04745011039712On the market Reusable Pressure Infusion Bag47450110397NCZPOn the market 500ml,1000ml,3000ml, 5000ml47450110397NX34On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.