Identify Health Drug Screen Test Cup ID-H6-1

GUDID 00850013035519

Identify Health Drug Screen Test Cup AMP500/COC150/OPI300/OXY100/PCP25,THC50

MEDICAL DISTRIBUTION GROUP INC

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 00850013035519
• NIH Device Record Key: a9463480-e1cf-4923-b03d-6efcf9cda956
• Commercial Distribution Discontinuation: 2045-11-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Identify Health Drug Screen Test Cup
• Version Model Number: ID-H6-1
• Catalog Number: ID-H6-1
• 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: true
• 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	00850013035519 [Unit of Use]
GS1	10850013035516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

FDA Product Code

• DIO: Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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: 2024-08-30
• Device Publish Date: 2024-08-22

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
• 00850013035519: Identify Health Drug Screen Test Cup AMP500/COC150/OPI300/OXY100/PCP25,THC50
• 00850013036004: Identify Health 6 Panel Drug Screen Test Cup - CLIA Waived AMP500, COC150, MET500, OPI300, PCP2