AMIES 2 ML FLOCK NASO 80+STD 80+URET 80 PEEL

Organization name

Deltalab, S.L.

SRN

ES-MF-000000153

Manufacturer status

Active

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

• CW010

  1. If the individual packaging breaks, do not use the product as there is no guarantee of sterility. 2. Do not use if any component is missing or if the printed information on the product is not displayed correctly. 3. Dispose of the device if any swabs are found to be dirty, broken and/or with splinters and/or with the head not compacted and/or missing. 4. Do not use after the expiry date. 5. Do not use if any alteration, dehydration or contamination of the transport medium is observed. 6. Handle with care. Although unlikely, exerting too much pressure during use could break the swab. In case of breakage, dispose of it immediately. 7. Wash or rinse with plenty of water if liquid comes into contact with skin, eyes or mouth. Do not ingest. Do not inhale. 8. For single use only; reuse of this device may lead to infection. 9. The use of the kit presents no difficulty for the intended users. 10. Not suitable for any application other than its intended use

Primary placement in Spain; available across 1 country total.

Trade name

AMIES 2 ML FLOCK NASO 80+STD 80+URET 80 PEEL

UDI-DI code

08435605818491

Basic UDI-DI

84356058UDI-DI-3067

Reference / catalog number

304227KP.3S

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

6

Additional product description

The kits consist of sterile surgical swabs and transport media. The swabs are medical devices, and the tubes containing transport media are in vitro diagnostic medical devices. The sterile swab sample collection kits are individually packaged. The kit does not include the materials required for the isolation and culture of microorganisms.

Additional information URL

https://www.deltalabgroup.com/eifus

Clinical sizes

No clinical sizes registered for this device.

• W05019099SAMPLES COLLECTION DEVICES - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
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