Sparky the Dog Pediatric Nebulizer

GUDID 00372217005032

Sparky the Dog Pediatric Nebulizer

ARISE MEDICAL LLC

Nebulizing system delivery set, reusable

• Primary Device ID: 00372217005032
• NIH Device Record Key: 808d9598-c2c0-467f-80d7-d17ea1bfbca5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sparky the Dog Pediatric Nebulizer
• Version Model Number: 240485
• Company DUNS: 081149273
• Company Name: ARISE MEDICAL 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00372217005032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043238

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2019-05-10
• Device Publish Date: 2019-05-02

Devices Manufactured by ARISE MEDICAL LLC

• 00372217036081 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - M- 100 Ct
• 00372217036098 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - L- 100 Ct
• 00372217036104 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - XL- 100 Ct
• 00372217036319 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - XS- 100 Ct
• 00372217036326 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - S- 100 Ct
• 00372217004035 - Procare Basic Upper Arm BP Monitor: 2020-08-31 Upparm Arm blood pressure monitor with standard cuff
• 00372217004042 - Procare Upper Arm BP Monitor with XL Cuff: 2020-08-31 Procare Upper Arm BP Monitor with XL Cuff
• 00372217005094 - Safari Express Pediatric Nebulizer: 2020-08-31 Safari Express Pediatric Nebulizer