ri-integral set Macintosh XL 2.5 V, with C-handle, 8040

GUDID 04045396008274

The laryngoscopes are manufactured in order to be used for endotracheal intubation. The Riester battery handles are used in order to supply the bulbs with energy and for fixation of the blades.

Rudolf Riester GmbH

Rigid intubation laryngoscope, reusable Rigid intubation laryngoscope, reusable Rigid intubation laryngoscope, reusable Rigid intubation laryngoscope, reusable Rigid intubation laryngoscope, reusable Rigid intubation laryngoscope, reusable Rigid intubation laryngoscope, reusable Rigid intubation laryngoscope, reusable Rigid intubation laryngoscope, reusable Rigid intubation laryngoscope, reusable

• Primary Device ID: 04045396008274
• NIH Device Record Key: 1698dca8-4720-4268-b10f-2ace5743b9fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ri-integral set Macintosh XL 2.5 V, with C-handle,
• Version Model Number: 8040
• Catalog Number: 8040
• Company DUNS: 537208717
• Company Name: Rudolf Riester GmbH
• 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: false
• 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	04045396008274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945425

FDA Product Code

• CCW: Laryngoscope, Rigid

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: 2021-02-05
• Device Publish Date: 2021-01-28

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