RespArray Temperature probe

GUDID 06944413839519

Edan Instruments, Inc.

General-purpose patient temperature probe, reusable

• Primary Device ID: 06944413839519
• NIH Device Record Key: cfcd1f37-99f4-4a86-bca3-d1b1d3a0aeb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RespArray Temperature probe
• Version Model Number: 02.57.225244
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413839519 [Primary]
GS1	16944413839516 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220308

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-29
• Device Publish Date: 2024-04-19

On-Brand Devices [RespArray Temperature probe]

• 06944413824737: 01.15.040551
• 06944413839533: 02.57.225245
• 06944413839526: 02.57.225243
• 06944413839519: 02.57.225244
• 06944413839502: 02.57.225246