GUDID 00385640000260

SUMMIT MEDICAL, INC.

Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile

• Primary Device ID: 00385640000260
• NIH Device Record Key: 87c56746-ecd3-4b22-9759-ea5f464285f1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: RG100
• Company DUNS: 965484699
• Company Name: SUMMIT MEDICAL, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640000260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911785

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2016-10-05

Devices Manufactured by SUMMIT MEDICAL, INC.

• 00385640081009 - INSTRUSAFE: 2024-05-15
• 00385640081016 - INSTRUSAFE: 2024-05-15
• 00385640080996 - INSTRUSAFE: 2024-05-14
• 00385640080972 - INSTRUSAFE: 2024-05-13
• 00385640080989 - INSTRUSAFE: 2024-05-13
• 00385640080958 - INSTRUSAFE: 2024-05-08
• 00385640080965 - INSTRUSAFE: 2024-05-08
• 00385640080910 - INSTRUSAFE: 2024-05-07