View source for Teltoheart UDI

[[Category:TeltoHeart]]

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<div style="font-size: 30px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 10px;">Unique Device Identifier <span style="color:#63b3ed;">(UDI)</span></div>
<div style="color: #a0aec0; font-size: 14px; line-height: 1.7; max-width:700px;">A unique numeric or alphanumeric code used to identify medical devices throughout the healthcare supply chain — from manufacturing through distribution to patient use. UDIs appear on device labels in both human-readable and machine-readable (barcode) formats.</div>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1.5px; color: #a0aec0; margin-bottom: 16px;">📄 Description</div>
<div style="font-size: 14px; color: #2d3748; line-height: 1.8; margin-bottom: 20px;">The UDI system was established to unambiguously identify specific medical devices on the market and facilitate their traceability. It is a regulatory requirement across major health authorities including the EU (EUDAMED) and US (FDA). The UDI consists of two parts:</div>

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<div style="font-size:11px; font-weight:700; text-transform:uppercase; letter-spacing:1px; color:#276749; margin-bottom:8px;">🔒 Device Identifier (DI)</div>
<div style="font-size:13px; color:#2d3748; line-height:1.7;">The <strong>mandatory, fixed</strong> portion of the UDI. Identifies the labeler and the specific version or model of a device. This value is the same for all units of the same product model.</div>
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<div style="font-size:11px; font-weight:700; text-transform:uppercase; letter-spacing:1px; color:#9b2335; margin-bottom:8px;">🔄 Production Identifier (PI)</div>
<div style="font-size:13px; color:#2d3748; line-height:1.7;">The <strong>variable</strong> portion of the UDI. Identifies production-specific characteristics such as batch/lot number, manufacturing date, expiration date, or serial number.</div>
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<strong>💡 GS1 Application Identifiers (AI)</strong><br/>
The codes in parentheses are GS1 Application Identifiers: <strong>(01)</strong> = GTIN (Global Trade Item Number), <strong>(10)</strong> = Batch/Lot Number, <strong>(11)</strong> = Manufacturing Date, <strong>(8012)</strong> = Software Version.
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1.5px; color: #a0aec0; margin-bottom: 8px;">🏷️ TeltoHeart UDI Codes</div>
<div style="font-size:13px; color:#718096; margin-bottom:20px;">Hardware device — includes batch number and manufacturing date as Production Identifiers.</div>

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<span style="color:#3182ce; font-weight:700;">(01)</span>04779051850181<br/>
<span style="color:#e53e3e; font-weight:700;">(10)</span>Batch number<br/>
<span style="color:#d69e2e; font-weight:700;">(11)</span>Manufacturing date
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<span style="color:#3182ce; font-weight:700;">(01)</span>04779051850167<br/>
<span style="color:#e53e3e; font-weight:700;">(10)</span>Batch number<br/>
<span style="color:#d69e2e; font-weight:700;">(11)</span>Manufacturing date
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<span style="color:#3182ce; font-weight:700;">(01)</span>04779051850198<br/>
<span style="color:#e53e3e; font-weight:700;">(10)</span>Batch number<br/>
<span style="color:#d69e2e; font-weight:700;">(11)</span>Manufacturing date
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<span><span style="color:#3182ce; font-weight:700;">(01)</span> GTIN — Device Identifier</span>
<span><span style="color:#e53e3e; font-weight:700;">(10)</span> Batch / Lot Number</span>
<span><span style="color:#d69e2e; font-weight:700;">(11)</span> Manufacturing Date</span>
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1.5px; color: #a0aec0; margin-bottom: 8px;">🏷️ MyHealth app UDI Code (used in TeltoHeart and TeltoCare software)</div>
<div style="font-size:13px; color:#718096; margin-bottom:20px;">Software device — includes software version number as the Production Identifier.</div>

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<span style="color:#3182ce; font-weight:700;">(01)</span>04779051850174<br/>
<span style="color:#6b46c1; font-weight:700;">(8012)</span>1.0.0
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<span><span style="color:#3182ce; font-weight:700;">(01)</span> GTIN — Device Identifier</span>
<span><span style="color:#6b46c1; font-weight:700;">(8012)</span> Software Version Number</span>
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<div style="padding:11px 16px; border-radius:8px; font-size:13px; font-weight:600; color:#2b6cb0; background:#ebf8ff; border:1px solid #bee3f8;">[https://health.ec.europa.eu/medical-devices-topics-interest/unique-device-identifier-udi_en 🌐 European Commission — UDI for Medical Devices →]</div>
<div style="padding:11px 16px; border-radius:8px; font-size:13px; font-weight:600; color:#2b6cb0; background:#ebf8ff; border:1px solid #bee3f8;">[https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics 🌐 FDA — UDI Basics →]</div>
<div style="padding:11px 16px; border-radius:8px; font-size:13px; font-weight:600; color:#2b6cb0; background:#ebf8ff; border:1px solid #bee3f8;">[https://www.gs1.org/industries/healthcare/udi 🔍 GS1 — UDI Standards →]</div>
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[[Category:TeltoHeart Nomenclature, classification codes]]