Medical device manufacturers and others involved in the supply chain have a responsibility to provide detailed information about medical devices. This information can be included on the packaging or in the accompanying documents. When it comes to materials or sterile barrier systems used in healthcare, the information that needs to be supplied can include, but is not restricted to, the following examples:
1.The name or trade name and address of the manufacturer and/or the manufacturer’s authorized representative.
The symbol represents the manufacturer of the medical device. Right after this symbol, people should find the manufacturer’s name and address. This is important as it helps identify the responsible party and provides a means of contact for any inquiries or concerns related to the device.
The symbol represents the entity or distributor responsible for distributing the medical device within a specific locale. It is a regulatory requirement that this symbol is accompanied by the name and address of the distributing entity, which should be placed adjacent to the symbol.
Including the name and address of the distributor allows for clear identification and traceability of the responsible party for the medical device. This information ensures transparency and accountability, enabling users to easily contact the distributor if needed.
By complying with this requirement and displaying the necessary information, the distributor demonstrates their commitment to providing safe and reliable medical devices to the local market while also facilitating effective communication with users.
2. The type, size or grade
The information in the picture shows that the disposable infusion set type is IS-GA-ZY3, and it comes with a needle size of 22G (0.7*38mm). This information helps identify and select the appropriate infusion set for medical purposes.
3. Batch number or other means of tracing the manufacturing history
The symbol indicates the manufacturer’s batch code. This code is unique to each batch or lot of the medical device and helps in identifying and tracking specific groups of devices produced by the manufacturer. It contributes to quality control and allows for easy traceability in case of any issues or recalls related to a particular batch or lot.
4. The intended sterilization processes and processing methods
The symbol indicates that the medical device, such as disposable syringes and IV sets, has undergone sterilization using ethylene oxide (EO). EO sterilization is a common method used to ensure that medical devices are free from harmful microorganisms before use. This symbol provides important information to healthcare professionals and end-users, indicating that the device has been properly sterilized using EO, which helps maintain its safety and effectiveness.
5. The expiry date, if applicable
The symbol indicates the expiration date of the medical device. It represents the specific date after which the device should not be used. It serves as an important safety measure to ensure that the device is used within its intended timeframe and remains effective and reliable. It’s crucial to adhere to this expiration date to maintain the device’s quality and minimize any potential risks associated with using an expired medical device.
6. Any specific storage conditions, if applicable
The symbol indicates a medical device that requires protection from light sources and should be kept away from heat.
The symbol indicates that the medical device needs protection from moisture. It serves as a reminder to keep the device away from any sources of moisture, such as rain or excessive humidity.
Given this information, it becomes even more important to store disposable syringes, and IV sets in a dry, well-ventilated, clean room. Along with using a moisture-proof pad and maintaining a distance of at least 20 cm from the wall, it is crucial to ensure that these devices are kept away from any moisture sources to maintain their integrity and sterility.
7. Any known restrictions on handling or use (e.g. environmental conditions), if applicable
The symbol represents a medical device that is intended for one single use only. This symbol serves as a reminder that our syringes and IV sets are designed for a single-use purpose and should be discarded after use. It is essential not to reuse these devices or use them in any other area or context.
Furthermore, it is crucial to handle and dispose of these single-use medical devices according to the regulations and guidelines outlined in medical waste management. This ensures the safe and proper disposal of these items, minimizing any potential risks or hazards associated with improper waste management.
Adhering to these guidelines can help maintain patient safety, reduce the risk of contamination, and support responsible waste management practices.
The symbol indicates that the medical device should not be used if the package has been damaged or opened. This serves as a crucial safety reminder to users. This pacakge usually refers to the sterile barrier system.
In the case of our syringes and IV sets, it is imperative to ensure that the primary package remains intact and undamaged. If the primary packaging is compromised in any way, it is best to refrain from using the product. This helps reduce the risk of contamination or other potential issues that may arise.
For further guidance and information, it is always advisable to consult the instructions for use provided with the product. These instructions will provide additional details on proper usage, handling, and any specific considerations regarding the sterile barrier system or packaging.
8. Whether the materials and/or preformed sterile barrier systems are intended for sing use or reuse
9. For reusable materials and/or reusable preformed sterile barrier systems, instructions for use including the frequency and nature of maintenance, laundering and/or cleaning, sterilization, inspection for damage or wear.
10. If instructions for use are supplied, the date of issue or revision check more labels