Safe-T-Way

GUDID 55099169209898

Oval MOUTHPIECES

VITALOGRAPH (IRELAND) LIMITED

Breathing mouthpiece, single-use

• Primary Device ID: 55099169209898
• NIH Device Record Key: fea77648-c4cb-4f01-a8e0-ca15d18e5f80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safe-T-Way
• Version Model Number: 2024
• Company DUNS: 219683489
• Company Name: VITALOGRAPH (IRELAND) LIMITED
• 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: 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099169209893 [Package]; Contains: 15099169209890; Package: [50 Units]; In Commercial Distribution
GS1	15099169209890 [Primary]
GS1	55099169209898 [Package]; Contains: 05099169209893; Package: [108 Units]; In Commercial Distribution

FDA Product Code

• BZG: SPIROMETER, DIAGNOSTIC

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: 2020-03-23
• Device Publish Date: 2018-05-15

On-Brand Devices [Safe-T-Way]

• 05099169297982: STRUT WATERS PO
• 05099169297975: MNT BKT MWATERS POT
• 55099169297710: 2024 SafeTway MOUTHPIECES INSPIRATORY AIM
• 55099169209898: Oval MOUTHPIECES
• 05099169209800: 2024 SafeTway MOUTHPIECES MINI
• 05099169209299: ECO SafeTway MOUTHPIECES
• 55099169209249: 2024 SAFETWAY MOUTHPIECE
• 55099169209225: 2024 SAFETWAY MOUTHPIECE
• 55099169209201: 2024 SAFETWAY MOUTHPIECES
• 55099169203926: FRONT BITE-ON MOUTHPIECES
• 55099169202462: 2024 SafeTway MOUTHPIECES 200 IN BAGS OF 25
• 05099169202429: 20242 Safe-T-Way Mouthpiece
• 05099169202023: MINI MOUTHPIECES
• 05099169202016: STANDARD DISPOSABLE MOUTHPIECES
• 05099169297722: SPACER TRAINER