ri-standard set Macintosh, with 7040

GUDID 04045396008038

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: 04045396008038
• NIH Device Record Key: bf674576-cc6d-4db5-bfb7-272931a00286
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ri-standard set Macintosh, with
• Version Model Number: 7040
• Catalog Number: 7040
• 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	04045396008038 [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

Devices Manufactured by Rudolf Riester GmbH

• 04045396007017 - Pack of 6 pcs. ri-pen® red: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120310 - ri-pen® blue: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120341 - ri-pen® green: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120389 - ri-pen® silver: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120464 - ri-pen® black: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396120525 - ri-pen® red: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.
• 04045396198487 - e-xam XL 2.5 V, black: 2021-07-27 The Riester diagnostic light is used for examination.
• 04045396198562 - Pack of 6 pcs. ri-pen®, violett: 2021-07-27 The Riester diagnostic light is used for ophthalmological examination.