SPIRO-BALL

GUDID 18436020761840

Volumetric Exerciser 4000mL

LEVENTON SAU

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• Primary Device ID: 18436020761840
• NIH Device Record Key: 9176dfec-b966-41b2-a012-02d3d0447879
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIRO-BALL
• Version Model Number: L25913000
• Company DUNS: 461437429
• Company Name: LEVENTON SAU
• 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: 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	08436020761843 [Primary]
GS1	18436020761840 [Package]; Contains: 08436020761843; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053149

FDA Product Code

• BWF: Spirometer, Therapeutic (Incentive)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-11-17
• Device Publish Date: 2017-06-12

Devices Manufactured by LEVENTON SAU

• 18436020761833 - TRI-BALL: 2023-11-17 Respiratory Exerciser
• 18436020761840 - SPIRO-BALL: 2023-11-17Volumetric Exerciser 4000mL
• 18436020761840 - SPIRO-BALL: 2023-11-17 Volumetric Exerciser 4000mL
• 18436020769150 - DOSI-FLOW: 2023-09-18 Regulator Extension Set with Female Luer Connector, Flow Regulator, Injection Site, and Rotating Luer Lock Connector
• 18436020769167 - DOSI-FLOW: 2023-09-18 Regulator Extension Set with Female Luer Connector, Flow Regulator, Needle-Free Injection Site, and Rotating Luer Lock Connector
• 18436020769174 - DOSI-FLOW: 2023-09-18 Regulator IV Set with Universal Spike (20 drops/mL) with 15 Micron Filter, On/Off Clamp, Flow Regulator, Injection Site, and Rot
• 18436020769181 - DOSI-FLOW: 2023-09-18 Regulator IV Set with Universal Spike (20 drops/mL) with 15 Micron Filter, On/Off Clamp, Flow Regulator, Needle-Free Injection S
• 08436020768828 - DOSI-FLOW: 2023-08-18 I.V. Flow Regulator with Pedriatic Set (60drops/ml)
• 08436020768835 - DOSI-FLOW: 2023-08-18 I.V. Flow Regulator with Adult Set (20drops/ml)