Nebu-Life RTG-07100

GUDID 10853292007472

Nebu-Life Hand Held Nebulizer 6cc Cup. The Jet Nebulizer Bottle Set is used to administer various aerosal treatments to adults and pediatric patients in both the homecare and hospital settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

CUTTING EDGE HC BRANDS LLC

Medicine chamber spacer, single-use

• Primary Device ID: 10853292007472
• NIH Device Record Key: d3ab55d1-eb36-4534-9b0f-9310e40f0733
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nebu-Life
• Version Model Number: RTG-07100
• Catalog Number: RTG-07100
• Company DUNS: 080216804
• Company Name: CUTTING EDGE HC BRANDS LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9999999999
• Email: info@rtghealth.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853292007475 [Primary]
GS1	10853292007472 [Package]; Contains: 00853292007475; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091272

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: 2
• Public Version Date: 2020-05-11
• Device Publish Date: 2019-02-25

On-Brand Devices [Nebu-Life]

• 10853292007533: Nebu-Life Hand Held Nebulizer 6cc Cup, w/ Pediatric Aerosol Elongated Mask & 7' Tube (2.1m). P
• 10853292007526: Nebu-Life Hand Held Nebulizer 6cc Cup, w/Adult Aerosol Elongated Mask & 7' Tube (2.1m). ADULT.
• 10853292007519: Nebu-Life Hand Held Nebulizer Kit 6cc Cup, T Adaptor, Mouthpiece, 7' (2.1m) Tubing, 6" Flextube
• 10853292007502: Nebu-Life Hand Held Nebulizer Kit 6cc Cup, T Adaptor, Mouthpiece, 7' (2.1m) Tubing, 6" Flextube
• 10853292007496: Nebu-Life Hand Held Nebulizer 6cc Cup, w/7' Tube (2.1m), Mouthpiece & T-Adaptor. The Jet Nebuli
• 10853292007489: Nebu-Life Hand Held Nebulizer 6cc Cup, w/7' Tube (2.1m). The Jet Nebulizer Bottle Set is used t
• 10853292007472: Nebu-Life Hand Held Nebulizer 6cc Cup. The Jet Nebulizer Bottle Set is used to administer variou