NebuTech 8990TG-7-50

GUDID 10607411976237

Disposable NebuTech Nebulizer, mouthpiece, 7 ft tubing w/thread grip connector B/V adaptor, and Expiratory Bacterial/Viral Filter

SALTER LABS

Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated

• Primary Device ID: 10607411976237
• NIH Device Record Key: acc42bde-ed23-4e4d-892b-e2fe7f0e2afb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NebuTech
• Version Model Number: 8990TG-7-50
• Catalog Number: 8990TG-7-50
• 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: true
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10607411976237 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-03
• Device Publish Date: 2023-09-25

Devices Manufactured by SALTER LABS

• 30889483610958 - Salter ETCo2/O2 Cannula: 2024-04-08 Adult. O2/ETCO2 Filtered Oral/Nasal Divided Soft Cannula, 7' O2 line, 6' ETCO2 line
• 10889483610961 - Salter ETCo2/O2 Cannula: 2024-04-08 Adult. O2/ETCO2 Filtered Oral/Nasal Divided Soft Cannula, 7' O2 line, 13' ETCO2 line
• 30889483610989 - Salter ETCo2/O2 Cannula: 2024-04-08
• 30889483610996 - Salter ETCo2/O2 Cannula: 2024-04-08 Adult. O2/ETCO2 Filtered Nasal Divided Soft Cannula, 7' O2 line, 13' ETCO2 line
• 30889483611009 - Salter ETCo2/O2 Cannula: 2024-04-08 Adult. O2/ETCO2 Filtered Oral/Nasal Divided Soft Cannula, 7' O2 line, 6' ETCO2 line, for prolonged duration
• 30889483611016 - Salter ETCo2/O2 Cannula: 2024-04-08 Adult. O2/ETCO2 Filtered Nasal Divided Soft Cannula, 7' O2 line, 6' ETCO2 line, for prolonged duration use
• 30889483611023 - Salter ETCo2/O2 Cannula: 2024-04-08 Pediatric. O2/ETCO2 Filtered Oral/Nasal Divided Soft Cannula, 7' O2 line, 6' ETCO2 line, for prolonged duration of use
• 30889483611146 - Salter ETCo2/O2 Cannula: 2024-04-08 Pediatric. O2/ETCO2 Filtered Oral/Nasal Divided Soft Cannula, 7' O2 line, 6' ETCO2 line