Resp-O2 Tracheostomy Care Kit, 3-Compartment Tray, Nitrile Gloves

GUDID 00840117321373

(1) Three-compartment tray (1) Pair of nitrile gloves (1) 3-Ply waterproof drape (4) Non-woven gauze, 4" × 4" (1) Tracheostomy dressing (2) Cotton-tipped applicators (1) Twill tape (2) Pipe cleaners (1) Tracheostomy brush (1) Sterile saline 0.9%, 100 mL (2) Hydrogen peroxide 1 oz. pack

DYNAREX CORPORATION

Tracheostomy care kit, single-use

• Primary Device ID: 00840117321373
• NIH Device Record Key: b5a7590f-5ef1-43ee-8e84-b28857295443
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Tracheostomy Care Kit, 3-Compartment Tray, Nitrile Gloves
• Version Model Number: 35005
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00840117321373 [Primary]
GS1	00840117321441 [Package]; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• LRQ: Tracheostomy And Nasal Suctioning Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-11
• Device Publish Date: 2022-10-03

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