AUM

GUDID 00850024759022

AUM Pediatric Compressor Nebulizer

Slv Pharmaceuticals LLC

Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory

• Primary Device ID: 00850024759022
• NIH Device Record Key: aecb0d09-30a2-4d39-9117-968400f527eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUM
• Version Model Number: BC68005
• Company DUNS: 081225162
• Company Name: Slv Pharmaceuticals 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: true
• Serial Number: true
• Manufacturing Date: true
• 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	00850024759022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091272

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2021-06-08
• Device Publish Date: 2020-11-16

On-Brand Devices [AUM]

• 00850024759022: AUM Pediatric Compressor Nebulizer
• 00850024759015: Compressor Nebulizer
• 00373317000125: AUM MINI PEN NEEDLES 33G - 6MM
• 00373317000118: AUM MINI PEN NEEDLES 33G - 5MM
• 00373317000149: AUM MINI PEN NEEDLES 33G - 4MM
• 00373317000095: AUM MINI PEN NEEDLES 32G - 8MM
• 00373317000101: AUM MINI PEN NEEDLES 32G - 6MM
• 00373317000088: AUM MINI PEN NEEDLES 32G - 5MM
• 00373317000071: AUM MINI PEN NEEDLES 32G - 4MM
• 00373317000040: AUM MINI PEN NEEDLES 31G - 8MM
• 00373317000057: AUM MINI PEN NEEDLES 31G - 6MM
• 00373317000026: AUM MINI PEN NEEDLES 31G - 5MM
• 00373317000033: AUM MINI PEN NEEDLES 31G - 4MM
• 00373317000064: AUM SAFETY PEN NEEDLES 32G -4MM
• 00373317568212: AUM MOISTURIZING GEL SOCKS