BluRapids TNR CDOA6125M
GUDID 10850011007294
BluRapids Concise CLIA Waived Drug Cup; 12-Panel; AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI300/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, 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 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 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 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 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 | 10850011007294 |
| NIH Device Record Key | 7072e8ca-cfcb-45d6-a552-c694785036fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BluRapids |
| Version Model Number | TNR CDOA6125M |
| Catalog Number | TNR CDOA6125M |
| 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 | true |
| 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
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850011007280 [Primary] |
| GS1 | 00850011007297 [Package] Contains: 00850011007280 Package: Inner Pack [25 Units] In Commercial Distribution |
| GS1 | 10850011007294 [Package] Contains: 00850011007297 Package: Case [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133968
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 | 2017-08-09 |
Devices Manufactured by MERCEDES MEDICAL, LLC
| 00860008185112 - BluTouch | 2023-05-23 Glove, Nitrile, Large, Powder Free, 100/box |
| 10860008185133 - BluTouch | 2023-05-23 Gloves, Nitrile, X-Large, BluTouch, Powder Free, 100/Box |
| 00850011007006 - Vacuflow™ | 2019-10-23 Butterfly, Vacuflow non-safety, w/adapter 21G 12" tubing 50/bx |
| 20850011007055 - Vacuflow™ | 2019-10-23 Butterfly, Vacuflow non-safety, w/adapter 23G 12" tubing 50/bx |
| 00850011007181 - Vacuflow™ | 2019-10-23 Butterfly, Vacuflow non-safety, w/adapter 25G 12" tubing 50/bx |
| 00850011007198 - Vacuflow™ | 2019-10-23 Vacuflow Butterfly Safety Luer Adapter 21g; 50bx |
| 20850011007208 - Vacuflow™ | 2019-10-23 Vacuflow Butterfly Safety Luer Adapter 23g; 50bx |
| 00850011007211 - Vacuflow™ | 2019-10-23 Butterfly Safety Luer Adapter 25g; 50bx |
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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