Noble Drug Test Cup (Urine)

GUDID 00858886006780

6AM10/AMP500/COC150/MDMA500/MET500/OPI300/OXY100/PCP25

NOBLE MEDICAL INC

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

• Primary Device ID: 00858886006780
• NIH Device Record Key: 999f7315-75ed-45e4-8a4b-50168823bf4c
• Commercial Distribution Discontinuation: 2080-05-05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Noble Drug Test Cup (Urine)
• Version Model Number: E-NMCup-08-34
• Company DUNS: 035967806
• Company Name: NOBLE MEDICAL 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858886006780 [Unit of Use]
GS1	10858886006787 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182123

FDA Product Code

• PVH: Test, Opiates, Employment And Insurance Testing, Exempt

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: 2023-05-15
• Device Publish Date: 2023-05-05

On-Brand Devices [Noble Drug Test Cup (Urine)]

• 00858886006513: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/THC50
• 00858886006506: 6AM10/AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/THC50
• 00858886006599: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50
• 00858886006582: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50
• 00858886006575: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50
• 00858886006681: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000
• 00858886006704: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000
• 00858886006728: AMP500/COC150/MET500/OPI300
• 00858886006742: AMP500/COC150/MET500/OPI300
• 00858886006773: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000
• 00858886006780: 6AM10/AMP500/COC150/MDMA500/MET500/OPI300/OXY100/PCP25
• 00858886006797: 6AM10/AMP500/COC150/MDMA500/MET500/OPI300/OXY100/PCP25
• 00858886006803: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25
• 00858886006841: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50