ETOH II_10 24 ETOH II_10 24

GUDID B800ETOHII10245

ETOH II_10 24

UTAK LABORATORIES, INC.

Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control

• Primary Device ID: B800ETOHII10245
• NIH Device Record Key: 03194da0-7cab-4da2-9bb3-535be6d50bc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETOH II_10 24
• Version Model Number: ETOH II_10 24
• Catalog Number: ETOH II_10 24
• Company DUNS: 092519016
• Company Name: UTAK LABORATORIES, 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: 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

Customer Support Contacts

• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com

Device Dimensions

• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter
• Total Volume: 1.25 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B800ETOHII10240 [Primary]
HIBCC	B800ETOHII10245 [Package]; Contains: B800ETOHII10240; Package: BOX [25 Units]; In Commercial Distribution

FDA Product Code

• LAS: Drug Specific Control Materials

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: 2024-06-28
• Device Publish Date: 2024-06-20

Devices Manufactured by UTAK LABORATORIES, INC.

• B800ETOHII06245 - ETOH II_06 24: 2024-06-28 ETOH II_06 24
• B800ETOHII07245 - ETOH II_07 24: 2024-06-28 ETOH II_07 24
• B800ETOHII08244 - ETOH II_08 24: 2024-06-28 ETOH II_08 24
• B800ETOHII09245 - ETOH II_09 24: 2024-06-28 ETOH II_09 24
• B800ETOHII10245 - ETOH II_10 24: 2024-06-28ETOH II_10 24
• B800ETOHII10245 - ETOH II_10 24: 2024-06-28 ETOH II_10 24
• B800TOXII06245 - TOX II_06 24: 2024-06-28 TOX II_06 24
• B800TOXII07240 - TOX II_07 24: 2024-06-28 TOX II_07 24
• B800TOXII08245 - TOX II_08 24: 2024-06-28 TOX II_08 24