BluRapids™ TNR CDOA261
GUDID 20850011007031
BlueRapids CLIA Waived Drug Cup; 6 Panel AMP/BZO/COC/MET/OPI2000/THC
MERCEDES MEDICAL, LLC
Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 20850011007031 |
| NIH Device Record Key | c1c6a1d2-b1fa-4b3f-9371-102f4d0cfd70 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BluRapids™ |
| Version Model Number | TNR CDOA261 |
| Catalog Number | TNR CDOA261 |
| 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 | 00850011007037 [Primary] |
| GS1 | 10850011007034 [Package] Contains: 00850011007037 Package: INNER PACK [25 Units] In Commercial Distribution |
| GS1 | 20850011007031 [Package] Contains: 10850011007034 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 | 3 |
| Public Version Date | 2018-07-06 |
| 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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