NebuTech® 8961-0

GUDID 10607411890441

NebuTech® HDN® Nebulizer with inhalation and exhalation Valve, mouthpiece. Disposable

SALTER LABS

Nebulizing system, non-heated

• Primary Device ID: 10607411890441
• NIH Device Record Key: fa96b0a0-2e21-4152-b94d-5c1407afc733
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NebuTech®
• Version Model Number: 8961-0
• Catalog Number: 8961-0
• Company DUNS: 022721133
• Company Name: SALTER LABS
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com
• Phone: +1(800)421-0024
• Email: customercare@salterlabs.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607411890444 [Primary]
GS1	10607411890441 [Package]; Contains: 00607411890444; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961476

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [NebuTech®]

• 10607411891851: NebuTech® HDN® Nebulizer with inhalation valve and Adult I-Guard™ valved mask-aerosol delive
• 10607411891837: NebuTech® HDN® Nebulizer with inhalation Valve and Pediatric I-Guard™ Valved Mask Aerosol De
• 10607411890564: NebuTech® HDN® Nebulizer with inhalation and exhalation valve, exhalation filter, mouthpiece,
• 10607411890526: NebuTech® HDN® Nebulizer (Adult) with aerosol mask, 7’ (2.1 m) supply tube, over-the-ear fix
• 10607411890502: NebuTech® HDN® Nebulizer with inhalation, 7' (2.1 m) supply tube, Adult aerosol mask, elasti
• 10607411890472: NebuTech® HDN® Nebulizer (Pediatric) with aerosol mask, 7’ (2.1 m) supply tube, over-the-ear
• 10607411890465: NebuTech® HDN® Nebulizer (Adult) with aerosol mask, 7’ (2.1 m) supply tube, over-the-ear fix
• 10607411890441: NebuTech® HDN® Nebulizer with inhalation and exhalation Valve, mouthpiece. Disposable
• 10607411890434: NebuTech® HDN® Nebulizer with inhalation valve, universal mask adaptor, mouthpiece, 7’ (2.1
• 20607411890356: NebuTech® HDN® Nebulizer with inhalation and exhalation valve, mouthpiece, 7’ (2.1 m) supply