Identify Health Drug Screen Test Cup ID-H9-1

GUDID 20850721007840

Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MET500/ MTD300/OPI300/OXY100

MEDICAL DISTRIBUTION GROUP INC

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• Primary Device ID: 20850721007840
• NIH Device Record Key: 5c01e758-b66b-4f86-a908-7839679d3330
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Identify Health Drug Screen Test Cup
• Version Model Number: ID-H9-1
• Catalog Number: ID-H9-1
• Company DUNS: 064177324
• Company Name: MEDICAL DISTRIBUTION GROUP INC
• Device Count: 25
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850721007846 [Unit of Use]
GS1	10850721007843 [Primary]
GS1	20850721007840 [Package]; Contains: 10850721007843; Package: case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

FDA Product Code

• DJC: Thin Layer Chromatography, Methamphetamine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-05-24
• Device Publish Date: 2019-02-27

On-Brand Devices [Identify Health Drug Screen Test Cup]

• 10850013035011: Identify Health CLIA Waived 7 Panel Drug Test Cup AMP500/BUP10/BZO300/COC150/OPI300/OXY100/THC50
• 20850721007857: Identify Health Drug Screen Test Cup AMP500/BZO300/COC150/OPI300/OXY100/THC50
• 20850721007840: Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MET500/ MTD300/OPI300/OXY
• 20850721007833: Identify Health Drug Screen Test Cup AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/ MET500/MTD300/OP