SmartPAN

Organization name

Magle Chemoswed AB

SRN

SE-MF-000003569

Manufacturer status

Active

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

• CW999

  Cautions:: For the safe use of SmartPAN the preparation and administration have to be done by health care professionals experienced with pancreatic surgery.  Extensive usage of thermoelectric hemostatic devises may alter tissue color and thereby impair visualization of SmartPAN indication.  Application of SmartPAN needs to be conducted carefully to place an even product layer on the tissue surface of interest without relevant time-delay during application. Optimal product layer covers tissue surface completely and homogenously without local heterogeneous increase of layer-thickness.  Syringe-style applicator allows for standardized usage to assure precise and comparable indicator reaction. SmartPAN appears orange when applied, but locally turns green-bluish over pancreatic leakage. This indicator reaction happens immediately or within seconds. Color change only appears in close proximity to relevant pancreatic leakage.  SmartPAN should be used immediately after removal of the cap to avoid contamination of the product.  SmartPAN is packaged for single patient use only. Discard remaining opened material after each medical procedure.  Do not re-sterilize SmartPAN.  Do not place SmartPAN in a procedure pack/tray that will be sterilized prior to use. Exposure of SmartPAN, to excessive heat (as in autoclaves or ethylene oxide sterilization) or radiation (such as gamma or electron beam) will alter its viscosity and may render the product unusable.  Do not use more than one device per treatment

Primary placement in Germany; available across 3 countries total.

Trade name

SmartPAN

UDI-DI code

073501080500C7X

Basic UDI-DI

B-073501080500C7X

Reference / catalog number

96 07 45

Issuing entity

HIBCC

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

SmartPAN is a biodegradable indicator intended for visual detection of biochemical leakage after tissue closure during surgical intervention

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

073501080500C7X

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• G99GASTROINTESTINAL DEVICES - OTHER