DART

GUDID 00841470100278

ENGINEERED MEDICAL SYSTEMS INC

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 Atomizer, non-ventilatory Atomizer, non-ventilatory

• Primary Device ID: 00841470100278
• NIH Device Record Key: 96e43ba1-740e-4460-8c8c-48d8016e5284
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DART
• Version Model Number: 2170-20300
• Company DUNS: 154502934
• Company Name: ENGINEERED MEDICAL SYSTEMS INC
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470100278 [Primary]
GS1	10841470100275 [Package]; Package: [25 Units]; In Commercial Distribution

FDA Product Code

• CCQ: Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

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: 2022-04-04
• Device Publish Date: 2022-03-25

On-Brand Devices [DART]

• 00841470100278: 2170-20300
• 10841470100268: 2170-20150
• 10841470100251: 2170-20100