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Organization name
UDI-DI code
Reference / catalog number

Pressure Infusion Bag — Class I MDD by NOXA MEDICAL OÜ

MD Atlas
NOXA MEDICAL OÜ

EUDAMED last updated this device on Jun 25, 2024

Pressure Infusion Bag

B-04745011039712

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: NOXA MEDICAL OÜ
UDI-DI code: 04745011039712
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	Jan 1, 2024	Dec 31, 2029
Estonia	Jan 1, 2024	Dec 31, 2029

Device identification

Trade name: Pressure Infusion Bag
UDI-DI code: 04745011039712
Basic UDI-DI: B-04745011039712
Reference / catalog number: 500ml,1000ml,3000ml, 5000ml
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC 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 single-use 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)

A088001PRESSURE INFUSION CUFFS, SINGLE-USE

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 Bag47450110397NCZPOn 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.