Wavelength

GUDID 00628108100127

Wavelength Ultrasound Lotion 5L

National Therapy Products Inc

Coupling gel, non-sterile

• Primary Device ID: 00628108100127
• NIH Device Record Key: 8959b9c0-e422-446c-8725-f68ddbaa02f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wavelength
• Version Model Number: NTPD500X
• Company DUNS: 200149883
• Company Name: National Therapy Products Inc
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628108100127 [Primary]
GS1	10628108100124 [Package]; Package: Box [4 Units]; In Commercial Distribution
GS1	20628108100121 [Package]; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013212

FDA Product Code

• MUI: Media,Coupling,Ultrasound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-05
• Device Publish Date: 2016-11-16

On-Brand Devices [Wavelength]

• 00628108100240: Wavelength HV Transmission Gel 210L
• 00628108100233: Wavelength Mini Pac Ultrasound Blue Gel Pouch 25g
• 00628108100226: Wavelength MP Multi Purpose Ultrasound Gel 100mL
• 00628108100202: Wavelength Multi-Purpose Ultrasound Gel w/ Twist Cap 250 mL
• 00628108100196: Wavelength Ultrasound Gel Clear 250mL
• 00628108100189: Wavelength Multi-Purpose Ultrasound Gel Blue 20L
• 00628108100172: Wavelength CL Multi Purpose Ultrasound Gel 100mL
• 00628108100165: Wavelength Ultrasound Lotion 3.78L
• 00628108100158: Wavelength LV Ultrasound Gel 4L
• 00628108100141: Wavelength MP Multi Purpose Ultrasound Gel 1L
• 00628108100134: Wavelength MP Multi Purpose Ultrasound Gel 16.9oz
• 00628108100127: Wavelength Ultrasound Lotion 5L
• 00628108100110: Wavelength TMS Gel 5L
• 00628108100103: Wavelength MP Multi Purpose Ultrasound Gel 5L
• 00628108100097: Wavelength HV Transmission Gel 5L
• 00628108100080: Wavelength LV Ultrasound Gel 5L
• 00628108100073: Wavelength CL Multi Purpose Ultrasound Gel 5L
• 00628108100066: Wavelength Ultrasound Lotion 8.45oz
• 00628108100059: Wavelength TMS Gel 8.45oz
• 00628108100042: Wavelength MP Multi Purpose Ultrasound Gel 8.45oz
• 00628108100035: Wavelength HV Gel 8.45oz
• 00628108100028: Wavelength LV Ultrasound Gel 8.45oz
• 00628108100011: Wavelength Multi Purpose Ultrasound Gel 8.45oz
• 10628108100346: Wavelength HV Gel High Viscosity w/ twist cap 250 mL
• 10628108100339: Wavelength HV Gel High Viscosity (bottle) 1L
• 10628108100322: Wavelength HV Clear Gel High Viscosity 200 mL
• 10628108100315: Wavelength HV Clear Gel High Viscosity (tube) 100 mL
• 10628108100308: Wavelength Ultrasound Lotion 1 USG
• 10628108100285: Wavelength Multi-Purpose Clear Ultrasound Gel 16.9 oz (500 mL)
• 00628108100271: Wavelength Ultrasound Gel Clear 25g
• 10628108100261: Wavelength LV Ultrasound Gel Low Viscosity 100mL
• 10628108100254: Wavelength MP Multi Purpose Ultrasound Gel 8.45 oz
• 00628108100400: Wavelength CL Ultrasound Gel Medium Viscosity 480mL
• 00628108100394: Wavelength MP Ultrasound Gel Medium Viscosity 480mL