Adimals® 2150

GUDID 00634782572433

Adimals Pulse Oximeter,Fingertip, Pediatric

AMERICAN DIAGNOSTIC CORP

Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 00634782572433
• NIH Device Record Key: 83a9b81f-369c-40c2-9507-054bef9bc697
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adimals®
• Version Model Number: 2150
• Catalog Number: 2150
• Company DUNS: 108999095
• Company Name: AMERICAN DIAGNOSTIC CORP
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634782072827 [Primary]
GS1	00634782572402 [Package]; Contains: 00634782872434; Package: Master Case [10 Units]; In Commercial Distribution
GS1	00634782572433 [Package]; Contains: 00634782872434; Package: Master Case [25 Units]; In Commercial Distribution
GS1	00634782872434 [Package]; Contains: 00634782072827; Package: Inner pack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070371

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Adimals®]

• 00634782572433: Adimals Pulse Oximeter,Fingertip, Pediatric
• 00634782563103: ADTEMP Adimal Dig. Thermometer,Dual Scale, Flex tip, Panda
• 00634782563097: ADTEMP Adimal Dig. Thermometer,Dual Scale, Flex tip, Koala
• 00634782563080: ADTEMP Adimal Dig. Thermometer,Dual Scale, Flex tip, Frog
• 00634782563073: ADTEMP Adimal Dig. Thermometer,Dual Scale, Flex tip, Bear
• 00634782560829: Chestpiece Snap-ons Kit-618,Pediatric, Set of 6
• 00634782860813: Chestpiece for 618 w/Panda,Pediatric, White
• 00634782860806: Chestpiece for 618 w/Panda,Pediatric, Seafoam
• 00634782860790: Chestpiece for 618 w/Panda,Pediatric, Pink
• 00634782560782: ADSCOPE Adimal Scope,Pediatric-30", White
• 00634782560775: ADSCOPE Adimal Scope,Pediatric-30", Seafoam
• 00634782560768: ADSCOPE Adimal Scope,Pediatric-30", Pink
• 00634782059989: Binaural/Tubing-617/618,22", White
• 00634782059972: Binaural/Tubing-617/618,22", Seafoam
• 00634782059965: Binaural/Tubing-617/618,22", Pink
• 00634782859749: Chestpiece for 617 w/Panda,Adult, White
• 00634782859732: Chestpiece for 617 w/Panda,Adult, Seafoam
• 00634782859725: Chestpiece for 617 w/Panda,Adult, Pink
• 00634782559663: Chestpiece Snap-ons Kit-617,Adult, Set of 6
• 00634782559656: ADSCOPE ADimal Scope,Adult-30", White