BluRapids™ TNR CDOA6125
GUDID 00850011007068
BluRapids CLIA Waived Drug Cup; 12 panel AMP/ BAR/BUP/BZO/COC/MDMA/MET/MTD/OPI-300/OXY/ PCP/THC
MERCEDES MEDICAL, LLC
Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical| Primary Device ID | 00850011007068 |
| NIH Device Record Key | 463e99db-81e2-4118-9d49-041d7bf0b766 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BluRapids™ |
| Version Model Number | TNR CDOA6125 |
| Catalog Number | TNR CDOA6125 |
| Company DUNS | 834472680 |
| Company Name | MERCEDES MEDICAL, LLC |
| Device Count | 1 |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from direct sunlight, moisture, and heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850011007068 [Primary] |
| GS1 | 10850011007065 [Package] Package: Inner Pack [25 Units] In Commercial Distribution |
| GS1 | 20850011007062 [Package] Contains: 10850011007065 Package: Case [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153050
FDA Product Code
| LDJ | Enzyme Immunoassay, Cannabinoids |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2016-08-15 |
On-Brand Devices [BluRapids™]
| 00850011007112 | BluRapids CLIA Waived Drug Cup; 13 Panel AMP,BAR,BZO,COC,MET,MDMA,OPI300,MTD,OXY,PCP,TCA,THC wit |
| 00850011007105 | BluRapids CLIA Waived Drug Cup; 13 Panel AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/TH |
| 00850011007099 | BluRapids CLIA Waived Drug Cup; 12 Panel BluRapids AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/ |
| 00850011007082 | BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC |
| 00850011007075 | BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/OPI2000/OXY/PCP/THC ; |
| 00850011007068 | BluRapids CLIA Waived Drug Cup; 12 panel AMP/ BAR/BUP/BZO/COC/MDMA/MET/MTD/OPI-300/OXY/ PCP/THC |
| 00850011007044 | BluRapids CLIA Waived Drug Cup; 6 Panel with Adulterants BZO/COC/MET/OPI/OXY/THC |
| 20850011007031 | BlueRapids CLIA Waived Drug Cup; 6 Panel AMP/BZO/COC/MET/OPI2000/THC |
| 10850011007027 | BlueRapids CLIA Waived Drug Cup; 5-Panal AMP/COC/PCP/OPI2000/THC |
| 20850011007017 | BluRapids CLIA Waived Drug Cup; 5-Panel AMP/COC/MET/OPI/THC |
Trademark Results [BluRapids]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BLURAPIDS 86725382 5087815 Live/Registered |
MERCEDES MEDICAL, LLC 2015-08-14 |
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