Resp-O2 Volumetric Incentive Spirometer

GUDID 00840117318182

Resp-O2 Volumetric Incentive Spirometer 5000mL

DYNAREX CORPORATION

Incentive spirometer

• Primary Device ID: 00840117318182
• NIH Device Record Key: 1a0f8b1b-2163-4f54-8c2e-38a050eee1de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Volumetric Incentive Spirometer
• Version Model Number: 36101
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117318182 [Package]; Contains: 00840117320918; Package: Case [12 Units]; In Commercial Distribution
GS1	00840117320918 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141355

FDA Product Code

• BWF: Spirometer, Therapeutic (Incentive)

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: 2021-04-30
• Device Publish Date: 2021-04-22

On-Brand Devices [Resp-O2 Volumetric Incentive Spirometer]

• 00840117318199: Resp-O2 Volumetric Incentive Spirometer Tri-Flow Chamber
• 00840117318182: Resp-O2 Volumetric Incentive Spirometer 5000mL
• 00840117320819: Resp-O2 Volumetric Incentive Spirometer 2500mL