NIFEDIPINE PLUS NIF+ S F EBS

GUDID B800NIFSFEBS5

NIFEDIPINE PLUS

UTAK LABORATORIES, INC.

Multiple drugs of abuse IVD, control

• Primary Device ID: B800NIFSFEBS5
• NIH Device Record Key: 3e983fc6-5064-4193-9895-4e34ca2cf328
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIFEDIPINE PLUS
• Version Model Number: NIF+ S F EBS
• Catalog Number: NIF+ S F EBS
• 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

Device Dimensions

• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B800NIFSFEBS0 [Primary]
HIBCC	B800NIFSFEBS5 [Package]; Contains: B800NIFSFEBS0; 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: 2024-06-05
• Device Publish Date: 2024-05-28

Devices Manufactured by UTAK LABORATORIES, INC.

• B80088121CDFF10NJSP5 - CERTIFIED DRUG FREE URINE: 2024-09-26 CERTIFIED DRUG FREE URINE
• B800DAU1V2NJSP5 - DRUGS OF ABUSE LEVEL 1: 2024-09-26 DRUGS OF ABUSE LEVEL 1
• B800DAU2V2NJSP5 - DRUGS OF ABUSE LEVEL 2: 2024-09-26 DRUGS OF ABUSE LEVEL 2
• B800DAU3NJSP5 - DRUGS OF ABUSE LEVEL 3: 2024-09-26 DRUGS OF ABUSE LEVEL 3
• B800DAU4NJSP5 - DRUGS OF ABUSE LEVEL 4: 2024-09-26 DRUGS OF ABUSE LEVEL 4
• B800FENT1V2UNJSP5 - FENTANYL PLUS LEVEL 1: 2024-09-26 FENTANYL PLUS LEVEL 1
• B800FENT1WBNJSP5 - FENTANYL PLUS LEVEL 1: 2024-09-26 FENTANYL PLUS LEVEL 1
• B800FENT2V2UNJSP5 - FENTANYL PLUS LEVEL 2: 2024-09-26 FENTANYL PLUS LEVEL 2