Digital Thermometer - Flexible Tip

GUDID 00616784561134

DYNAREX CORPORATION

Intermittent electronic patient thermometer

• Primary Device ID: 00616784561134
• NIH Device Record Key: 509ddea4-1abc-438c-b0b5-2a290bdfcbcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Thermometer - Flexible Tip
• Version Model Number: 5611
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784561110 [Primary]
GS1	00616784561127 [Package]; Contains: 00616784561110; Package: [12 Units]; In Commercial Distribution
GS1	00616784561134 [Package]; Contains: 00616784561127; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092447

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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• 00616784470429 - IV Start Kit with Nitrile Gloves, Sterile-EO: 2025-08-27
• 00616784704111 - IV Adminstration Set, 10 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784704210 - IV Administration Sets, 10 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784704418 - IV Administration Set, 20 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784304113 - Dmecare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 16"x16". Weight Capacity: 300 LB.