LBL-0553 Rev 1 Label, Pouch, Patch, D-Tect
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Otsuka America Pharmaceutical, Inc. 02684 Wearable Sensor for Ambulatory Recording X7902684 X7902684 02684
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02684 Wearable Sensor For Ambulatory Recording by Otsuka America Pharmaceutical
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Document DEVICE REPORT02684-ID-Label-Location-Info-Otsuka-America-Pharmaceutical-x7902684-ex-1-2LBL-0553 Rev 1 Label, Pouch, Patch, D-Tect Effective: 06JAN2023 Label, Pouch, Patch, D-Tect LBL-0553 Otsuka America Pharmaceutical, Inc. TMP-0078 Rev 3 Effective: 22JUN2022 Confidential Page 1 of 5 LBL-0553 Rev 1 Label, Pouch, Patch, D-Tect Effective: 06JAN2023 1 Purpose/Description This document is intended to define the artwork and label stock associated with the D-Tect Patch Pouch Variable Data Label. The label stock is a blank white label. All printing will be generated at the point of use. There is no procurement specification needed for this type of label due to the use of standard label stock and no preprinting. 2 Label Artwork File Graphics are defined by label file " LBL-0553 Label, Pouch, Patch, D-Tect" Label Stock The following label stock should be used. Manufacturer Description Weber Packaging Label Stock, 4" x 3" White Gloss Poly Direct Thermal Solutions Inc. Label corners have 1/8" radius. (Note: Radius size is not critical) (See attached label stock Product Information sheet) It is expected that the Contract Manufacturer for the patch assembly shall create their own specification for the label stock. Otsuka America Pharmaceutical, Inc. TMP-0078 Rev 3 Effective: 22JUN2022 Confidential Page 2 of 5 LBL-0553 Rev 1 Label, Pouch, Patch, D-Tect Effective: 06JAN2023 Content Requirements Characteristic Specification Variable Printed Content Printing shall include the following variable data: Reference part number Patch Serial Number Barcode the represents the Patch Serial Number Manufacturing Lot number o Code 128 format at 600dpi or better Expiration Date UDI (Unique Device Identifier): A GS1 DataMatrix barcode and human readable content containing the following: o Device Identifier: (01) NNNNNNNNNNNNNN o Expiration Date: (17) YYMMDD o Lot Number: (21) nnnnnnnnn o Serial Number: (10) NNNNNNNN Graphics Image Note: Arrows point to the variable data 4" 3" Serial Number with barcode UDI GS1 DataMatrix with human readable content Otsuka America Pharmaceutical, Inc. TMP-0078 Rev 3 Effective: 22JUN2022 Expiration Date Confidential Reference Number Pouched Patch Assembly Part Number Manufacturing Lot Number Page 3 of 5 LBL-0553 Rev 1 Label, Pouch, Patch, D-Tect 3 Attachment Label stock product information Effective: 06JAN2023 Otsuka America Pharmaceutical, Inc. TMP-0078 Rev 3 Effective: 22JUN2022 Confidential Page 4 of 5 LBL-0553 Rev 1 Label, Pouch, Patch, D-Tect Effective: 06JAN2023 4 Document History Rev Originator 1 Todd Shoenberger Description of Change Initial release of label document specification in support of D-Tect. Otsuka America Pharmaceutical, Inc. TMP-0078 Rev 3 Effective: 22JUN2022 Confidential Page 5 of 5
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- X7902684 - Otsuka America Pharmaceutical, Inc. Wearable Sensor for Ambulatory Recording [02684] Acrobat Distiller 22.0 (Windows)