13312

Organization name

AprioMed AB

SRN

SE-MF-000001013

Manufacturer status

Active

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

• CW999

  If using SeeStar® in conjunction with other equipment, first check that the equipment is compatible with SeeStar®. See table 1 in the IFU for maximum permissable needle diameter
• CW999

  Note that the needle holder is 4 cm long, which must be taken into account when calculating the puncture length of the needle.
• CW999

  Precaution 1: SeeStar® should only be used by, or under the supervision of a physician.
• CW999

  Precaution 2: Once SeeStar® has been taped to the skin, it could be dislodged if the skin moves. If the patient has been moved, a control image should be taken to check its location
• CW999

  Precaution 3: If an external needle is used, the needle holder should be loosened after puncture so as not to restrict unnecessarily the body’s normal internal movements
• CW999

  Precaution 4: After use, the components may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
• CW007

  EUDAMED did not publish a description for this code.
• CW027

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.

Primary placement in Sweden; available across 32 countries total.

Trade name

not provided

UDI-DI code

07350031350494

Basic UDI-DI

73500313514KN

Reference / catalog number

13312

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://apriomed.com/wp-content/uploads/29600.pdf

Clinical sizes

• 12

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

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

• A018002NEEDLE GUIDES