Apollo System

GUDID 00814548016382

Apollo Generator

PENUMBRA, INC.

Surgical irrigation/aspiration system Surgical irrigation/aspiration system

• Primary Device ID: 00814548016382
• NIH Device Record Key: 3c4ef263-7201-4096-8945-e2e4b0e9eba4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apollo System
• Version Model Number: APG1-A
• Company DUNS: 191077671
• Company Name: PENUMBRA, INC.
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814548016382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132931

FDA Product Code

• GWG: Endoscope, Neurological

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: 2019-02-04
• Device Publish Date: 2019-01-03

On-Brand Devices [Apollo System]

• 00814548017563: Apollo Pump, 110V
• 00814548016474: Apollo IV Pole
• 00814548016382: Apollo Generator
• 00814548016375: Apollo Pump Canister Kit
• 00814548016368: Apollo Irrigation Tubing
• 00814548016351: Apollo Wand, Short
• 00814548016344: Apollo Wand, Long
• 00814548013619: Apollo Pump Canister Kit
• 00814548013602: Apollo Irrigation Tubing
• 00814548013596: Apollo Wand, Short
• 00814548013589: Apollo Wand, Long
• 00814548012728: Apollo IV Pole
• 00814548012711: Apollo Pump
• 00814548012704: Apollo Generator